Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
FDA 510(k) clearance K143572 · decided 2015-06-10
Clearance details
- K-number
- K143572
- Device name
- Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
- Applicant
- Osteomed Implantes, Ltda
- Decision
- Substantially Equivalent
- Date received
- 2014-12-17
- Decision date
- 2015-06-10
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rio Claro - Sp, BR
- 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.