Smith & Nephew, Inc.
FDA 510(k) medical device clearances.
Clearances by Smith & Nephew, Inc. — page 2
101–200 of 532- K162078 — EVOS Small Fragment Plating System
- K160923 — REDAPT Anteverted Cemented Liner
- K161665 — VLP Wrist Fracture System
- K152163 — RENASYS GO
- K162129 — RENASYS-G Gauze Dressing Kits with Soft Port
- K160738 — ZUK Select Knee System
- K152566 — PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
- K150790 — REDAPT Porous Acetabular Shell and Cemented Liner
- K152976 — VLP Mini-Mod Talus Plates
- K152315 — JOURNEY II Uni Tibial Base and Insert
- K150241 — Genesis II XLPE Resurfacing Patellar Components
- K152726 — JOURNEY II XR Knee System
- K151902 — REDAPT¿ Revision Femoral System
- K152143 — TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
- K151105 — Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
- K143133 — RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
- K151326 — RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
- K143115 — The VersaJet II Hydrosurgery System
- K142979 — RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
- K143739 — POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
- K143096 — SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
- K143226 — Visionaire Disposable Instruments
- K143172 — ACL SMART System
- K142948 — BIOSURE REGENESORB interference Screw
- K142807 — ANTHEM PS Total Knee System
- K143050 — VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
- K142520 — Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
- K141471 — JOURNEY II XR KNEE SYSTEM
- K141585 — SMITH & NEPHEW DISPOSABLE FIN PUNCH
- K140879 — BIOSURE HEALICOIL PK INTERFERENCE SCREW
- K140555 — JOURNEY II BCS CONSTRAINED INSERTS
- K133662 — SMITH & NEPHEW CANNULATED CAPTURED SCREW
- K140814 — EVOS MINI-FRAGMENT PLATING SYSTEM
- K132886 — SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
- K132296 — D-RAD SMART PACK
- K132015 — TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
- K130708 — SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
- K132079 — TFCC FAST-FIX KIT
- K132357 — SMITH & NEPHEW ULTRATAPE
- K132446 — RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
- K132435 — SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
- K132636 — DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
- K130728 — POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
- K130748 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
- K123598 — SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
- K130479 — ILIZAROV DRILL TIP WIRES
- K123159 — SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
- K123393 — HEALICOIL SUTURE ANCHOR WITH REGENESORB
- K122059 — ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
- K123948 — CHINA NAILS AND ACCESSORIES
- K123425 — TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
- K123055 — SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
- K123579 — FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
- K122596 — ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
- K123012 — SMITH & NEPHEW SMF HIP STEM
- K122170 — SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
- K121861 — SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
- K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS
- K121627 — SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
- K113039 — SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
- K121714 — SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
- K122296 — SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
- K122244 — POLARCUP DUAL MOBILITY SYSTEM
- K121443 — JOURNEY II CR KNEE SYSTEM
- K121393 — SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
- K120211 — SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
- K121018 — BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
- K120871 — SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
- K120698 — GENESIS II PS NON-MODULAR FEMORAL COMPONENT
- K112127 — PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K113848 — R3 XLPE LINERS
- K113789 — MODULAR PROXIMALLY FLUTED HIP STEM
- K120667 — VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
- K113274 — FOOTPRINT ULTRA PK SUTURE ANCHOR
- K113482 — JOURNEY II DEEP DISHED ARTICULAR INSERTS
- K112526 — TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
- K113294 — SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
- K113012 — PROMOS MODULAR SHOULDER SYSTEM
- K113038 — SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
- K112941 — LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
- K111170 — PICO
- K112134 — TRUCLEAR OPERATIVE HYSTEROSCOPE
- K112784 — RENASYS AB ABOMINAL DRESSING KIT
- K112406 — PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
- K110135 — POLARCUP DUAL MOBILITY SYSTEM
- K111994 — SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
- K111711 — JOURNEY II BCS KNEE SYSTEM
- K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS
- K110958 — VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
- K110670 — VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
- K111025 — TRIGEN LOW PROFILE BONE SCREW
- K110545 — SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
- K110647 — RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
- K103793 — DURAFIBER AG
- K110837 — REVISION PROTHESIS
- K110240 — SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
- K110101 — TAPER OXINIUM FEMORAL HEAD
- K110038 — TRUCLEAR MORCELLATOR SYSTEM
- K103389 — TRUCLEAR INCISOR PLUS BLADE 2.9
- K110069 — SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.