INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
FDA 510(k) clearance K051821 · decided 2005-11-25
Clearance details
- K-number
- K051821
- Device name
- INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
- Applicant
- Inion , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-05
- Decision date
- 2005-11-25
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- OJB
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tampere, FI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Inion Spinal Graft Containment System (K151360) | Inion OY | 2015-10-06 |
| INION SPINAL GRAFT CONTAINMENT SYSTEM (K071810) | Inion , Ltd. | 2008-07-11 |
Recalls involving this device
No recalls on record reference this clearance.