ACUMED SMALL BONE LOCKING SYSTEM II
FDA 510(k) clearance K071944 · decided 2007-08-09
Clearance details
- K-number
- K071944
- Device name
- ACUMED SMALL BONE LOCKING SYSTEM II
- Applicant
- Acumed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-07-13
- Decision date
- 2007-08-09
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hillsboro, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.