WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
FDA 510(k) clearance K993903 · decided 2000-02-14
Clearance details
- K-number
- K993903
- Device name
- WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
- Applicant
- Whiteside Biomechanics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-16
- Decision date
- 2000-02-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Creve Coeur, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.