RESORBABLE CRANIAL CLAMPS— 510(k) K021408
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K021408 for RESORBABLE CRANIAL CLAMPS, Substantially Equivalent on 2002-07-29. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code GXR
view all- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- K221606 — Absorbable Cranial Flap Fixation System
- K192310 — Flap Fixator, Burr Hole Cover
- K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
More clearances from Synthes (Usa)
view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Data sourced from openFDA. This site is unofficial and independent of the FDA.