Inion Spinal Graft Containment System
FDA 510(k) clearance K151360 · decided 2015-10-06
Clearance details
- K-number
- K151360
- Device name
- Inion Spinal Graft Containment System
- Applicant
- Inion OY
- Decision
- Unknown
- Date received
- 2015-05-20
- Decision date
- 2015-10-06
- Days to decision
- 139 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 (K071810) | Inion , Ltd. | 2008-07-11 |
| INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM (K051821) | Inion , Ltd. | 2005-11-25 |
Recalls involving this device
No recalls on record reference this clearance.