Companion Spine DIAM™ Instrumentation
FDA 510(k) clearance K253118 · decided 2025-12-16
Clearance details
- K-number
- K253118
- Device name
- Companion Spine DIAM™ Instrumentation
- Applicant
- Companion Spine France
- Decision
- Substantially Equivalent
- Date received
- 2025-09-24
- Decision date
- 2025-12-16
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- QLR
- Device class
- 2
- Regulation number
- 888.4520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mérignac, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| coflex Interlaminar Stabilization Device (P110008/S013) | Companion Spine France | 2021-03-31 |
| coflex® Interlaminar Technology (P110008/S012) | Companion Spine France | 2020-08-05 |
| coflex Interlaminar Stabilization Device (P110008/S011) | Companion Spine France | 2020-04-07 |
| Paradigm Spine Coflex Interlaminar Stabilization Device (P110008/S009) | Companion Spine France | 2018-06-21 |
| coflex® Interlaminar Technology (P110008/S008) | Companion Spine France | 2018-04-25 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S010) | Companion Spine France | 2018-04-20 |
| COFLEX INTERLAMINAR TECHNOLOGY (P110008/S007) | Companion Spine France | 2017-03-10 |
| coflex® Interlaminar Technology (P110008/S006) | Companion Spine France | 2016-11-30 |