REPROCESSED PINS
FDA 510(k) clearance K100707 · decided 2010-06-25
Clearance details
- K-number
- K100707
- Device name
- REPROCESSED PINS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-12
- Decision date
- 2010-06-25
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- NDM
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.