LOOP CAGE
FDA 510(k) clearance K121332 · decided 2012-06-29
Clearance details
- K-number
- K121332
- Device name
- LOOP CAGE
- Applicant
- Advanced Medical Technologies AG
- Decision
- Substantially Equivalent
- Date received
- 2012-05-03
- Decision date
- 2012-06-29
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.