SMITH & NEPHEW PEEK INTERFERENCE SCREW
FDA 510(k) clearance K083226 · decided 2009-01-30
Clearance details
- K-number
- K083226
- Device name
- SMITH & NEPHEW PEEK INTERFERENCE SCREW
- Applicant
- Smith & Nephew Endoscopy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-03
- Decision date
- 2009-01-30
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.