FLOWER SMALL AND MEDIUM BONE IMPLANTS
FDA 510(k) clearance K123562 · decided 2013-03-29
Clearance details
- K-number
- K123562
- Device name
- FLOWER SMALL AND MEDIUM BONE IMPLANTS
- Applicant
- Flower Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-11-19
- Decision date
- 2013-03-29
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16 recall (Z-1314-2015) | Flower Orthopedics Corporation | 2015-03-24 |