GRS GLENOID RESURFACING SYSTEM
FDA 510(k) clearance K091196 · decided 2009-10-27
Clearance details
- K-number
- K091196
- Device name
- GRS GLENOID RESURFACING SYSTEM
- Applicant
- Arthrosurface, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-23
- Decision date
- 2009-10-27
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Franklin, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.