IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
FDA 510(k) clearance K970292 · decided 1997-04-23
Clearance details
- K-number
- K970292
- Device name
- IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
- Applicant
- Influence, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-24
- Decision date
- 1997-04-23
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladde recall (Z-1235-2008) | American Medical Systems | 2008-07-16 |