CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
FDA 510(k) clearance K101100 · decided 2010-08-26
Clearance details
- K-number
- K101100
- Device name
- CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
- Applicant
- Conmed Linvatec
- Decision
- Substantially Equivalent
- Date received
- 2010-04-20
- Decision date
- 2010-08-26
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures recall (Z-1619-2013) | Linvatec Corp. dba ConMed Linvatec | 2013-07-01 |