TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
FDA 510(k) clearance K013775 · decided 2002-01-08
Clearance details
- K-number
- K013775
- Device name
- TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
- Applicant
- Stryker Leibinger
- Decision
- Substantially Equivalent
- Date received
- 2001-11-13
- Decision date
- 2002-01-08
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.