SECURE Screw
FDA 510(k) clearance K191771 · decided 2019-10-16
Clearance details
- K-number
- K191771
- Device name
- SECURE Screw
- Applicant
- A.M. Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-02
- Decision date
- 2019-10-16
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Smithtown, NY, US
- Third-party review
- No
- Expedited review
- No
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| Arthrex Beaming System (K254215) | Arthrex, Inc. | 2026-05-08 |
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Recalls involving this device
No recalls on record reference this clearance.