ABSOLUTE ABSORBABLE INTERFERENCE SCREW
FDA 510(k) clearance K993975 · decided 1999-12-20
Clearance details
- K-number
- K993975
- Device name
- ABSOLUTE ABSORBABLE INTERFERENCE SCREW
- Applicant
- Innovasive Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-24
- Decision date
- 1999-12-20
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.