SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
FDA 510(k) clearance K111820 · decided 2012-03-14
Clearance details
- K-number
- K111820
- Device name
- SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
- Applicant
- Bm Korea Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-28
- Decision date
- 2012-03-14
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.