FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
FDA 510(k) clearance K221731 · decided 2022-09-07
Clearance details
- K-number
- K221731
- Device name
- FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-15
- Decision date
- 2022-09-07
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Kibbutz Gaaton, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.