CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
FDA 510(k) clearance K923869 · decided 1993-05-12
Clearance details
- K-number
- K923869
- Device name
- CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-03
- Decision date
- 1993-05-12
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.