MINI-H-FIXATION— 510(k) K792561
Substantially EquivalentGeny Medical, Inc.
FDA 510(k) clearance K792561 for MINI-H-FIXATION, Substantially Equivalent on 1979-12-19. Applicant: Geny Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Geny Medical, Inc.
- Product code
- Code JEC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
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