TiLock Modular Spinal System
FDA 510(k) clearance K172469 · decided 2017-11-30
Clearance details
- K-number
- K172469
- Device name
- TiLock Modular Spinal System
- Applicant
- Genesys Spine
- Decision
- Substantially Equivalent
- Date received
- 2017-08-15
- Decision date
- 2017-11-30
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.