EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
FDA 510(k) clearance K111471 · decided 2011-06-10
Clearance details
- K-number
- K111471
- Device name
- EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
- Applicant
- Medshape Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-27
- Decision date
- 2011-06-10
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of l recall (Z-1276-2013) | Medshape Solutions, INC. | 2013-05-08 |