ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
FDA 510(k) clearance K072840 · decided 2007-12-07
Clearance details
- K-number
- K072840
- Device name
- ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- Applicant
- Endius, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-04
- Decision date
- 2007-12-07
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plainville, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.