Product code JEC— Orthopedic
ACE WIRE TENSION CLAMP
- Classification name
- Component, Traction, Invasive
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Total cleared
- 85
- First cleared
- Most recent
Market context for product code JEC
FDA has cleared devices under product code JEC between 1976 and 2021, filed by 51 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2020
- 2019
- 2018
- 2016
- 2014
- 2011
- 2009
- 2008
- 2007
- 2004
- 2003
- 2002
- 2001
- 1999
Top applicants under product code JEC
Recent clearances under product code JEC
- K203605 — SteriTrak
- K193256 — Anjon Bremer Halo System
- K192465 — DigiFix Sterile Kit
- K181192 — PIP Fix
- K171863 — Anjon Bremer Halo System
- K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices
- K132731 — DIGIFIX EXTERNAL FIXATION SYSTEM
- K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
- K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
- K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
- K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
- K042066 — KLSA MARTIN HAND DISTRACTOR
- K032427 — FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
- K031941 — HOFFMANN II COMPACT BALTIMORE COUPLING
- K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
- K022676 — ORTHOGUARD AB ANTIMICROBIAL SLEEVE
- K022065 — SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
- K012193 — AMC ANTIMICROBIAL PIN/WIRE SLEEVE
- K013818 — AUTOGENESIS AUTOMATOR, MODEL M1000
- K003848 — HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
- K993099 — BREMER HALO SYSTEM TITANIUM SKULL PIN
- K991732 — CENTRAFIX EXTERNAL FIXATOR
- K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
- K981423 — AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
- K971755 — HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
- K965029 — STABLELOC II EXTERNAL FIXATOR
- K963614 — MONOTUBE CARBON TUBE
- K961916 — HOFFMANN II CARBON CONNECTING ROD
- K961618 — MONOTUBE TUBE TO RING CLAMP
- K960782 — TITANIUM TUBE TO TUBE CLAMP
- K954838 — EZ FIX
- K954667 — MONOTUBE TUBE-TO-TUBE CLAMP
- K952330 — EXTERNAL FIXATOR
- K952730 — HOFFMANN II EXTERNAL FIXATION SYSTEM
- K944092 — ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
- K943857 — EXTERNAL FIXATOR
- K933968 — ACE PELVIC STABILIZER
- K922796 — PELVIC C-CLAMP
- K931578 — TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
- K934698 — HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
- K936045 — ACE UNILATERAL FIXATOR II
- K936124 — HOWMEDICA MONOTUBE T-CONNECTOR
- K930153 — SYSTEM III HALO RING
- K920117 — HALO ESPRIT
- K920149 — OSTEO EX-FI-RE
- K915800 — BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
- K914858 — ACE OPEN-BACK HALO RING
- K894959 — CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
- K903105 — OLIVE K-WIRES
- K901984 — ACE WIRE TENSION CLAMP
- K894098 — SYNTHES EXTERNAL FIXATION BONE CLIP
- K894982 — ACE WIRE TENSION CLAMP
- K892638 — TRACER DYNAMIC AXIAL FIXATION
- K884798 — AME PINSITE SHIELD(TM)
- K884242 — MODIFIED CHICK AMBULATORY HALO
- K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE
- K881896 — KIRSCHNER SUPER-FIXATION SYSTEM
- K881673 — LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
- K880282 — LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
- K872538 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
- K852397 — EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
- K842493 — AGEE EXTERNAL FIXATOR
- K842343 — SABA-COOMBS MINI EXTERNAL FIXATOR
- K841334 — RICHARDS FIXATOR SYSTEM
- K840856 — MODULAR CONSTRUCT FRAME EXTERNAL FIXA
- K833114 — OXFORD MARK 2 EXTERNAL FIXATOR
- K831576 — ORTHOFIX
- K830154 — COLLES FRACTURE FRAME
- K822780 — CERVICAL BRACE
- K803166 — DOUBLE BALL JOINT
- K802814 — ORTHOFIX AXIALEXTERNAL FIXATION SYS.
- K802722 — EXTERNAL FIXATION SYSTEM
- K802723 — EXTENDED BALLJOINT GRIP
- K802776 — HOFFMAN LEG LENGTHENING DEVICE
- K800184 — OXFORD EXTERNAL FIXATION SYSTEM
- K792561 — MINI-H-FIXATION
- K791466 — ACE EXTERNAL BONE CLAMP PART #S11
- K790262 — UNIVERSAL EXTERNAL FIXATION ASSEMBLY
- K781839 — BONE CLAMP, ACE EXTERNAL
- K781840 — EXTERNAL ARTICULATION
- K781841 — BAR, DISTRACTION
- K781793 — FRAME, UNIVERSAL DAY
- K770066 — TIBIAL COMPRESSION FRAM FOR FRACTURES
- K770388 — FRACTURE REDUCTION SYS., MODEL OR 1001
- K761088 — DEPUY MODIFIED SKELETAL TRACTION PIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.