FEMORAL HOOK
FDA 510(k) clearance K041261 · decided 2004-06-07
Clearance details
- K-number
- K041261
- Device name
- FEMORAL HOOK
- Applicant
- Arthrotek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-11
- Decision date
- 2004-06-07
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for recall (Z-1782-2008) | Biomet Sports Medicine | 2008-09-04 |
| BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated for recall (Z-1783-2008) | Biomet Sports Medicine | 2008-09-04 |