SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP— 510(k) K041611
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K041611 for SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP, Substantially Equivalent on 2004-09-08. 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
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- 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.