DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
FDA 510(k) clearance K972183 · decided 1997-08-26
Clearance details
- K-number
- K972183
- Device name
- DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
- Applicant
- Ace Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-10
- Decision date
- 1997-08-26
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB D recall (Z-1196-2018) | Zimmer Biomet, Inc. | 2018-03-14 |
| AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL T recall (Z-1197-2018) | Zimmer Biomet, Inc. | 2018-03-14 |