WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
FDA 510(k) clearance K003618 · decided 2001-05-23
Clearance details
- K-number
- K003618
- Device name
- WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
- Applicant
- Whiteside Biomechanics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-22
- Decision date
- 2001-05-23
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- NDD
- 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.