Invictus® Bone Cement, Invictus Spinal Fixation System
FDA 510(k) clearance K221926 · decided 2022-12-20
Clearance details
- K-number
- K221926
- Device name
- Invictus® Bone Cement, Invictus Spinal Fixation System
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-01
- Decision date
- 2022-12-20
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- PML
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.