DIAM Spinal Stabilization System
FDA premarket approval P240043 · decided 2025-12-10
Approval details
- PMA number
- P240043
- Trade name
- DIAM Spinal Stabilization System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France Sas
- Date received
- 2024-12-06
- Decision date
- 2025-12-10
- Days to decision
- 369 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate to severe primary low back pain (greater than leg pain) secondary to lumbar degenerative disc disease (DDD), at a single level from L2-L5 with current episode refractory to at least 6 months of non-operative care.Symptomatic disc disease is confirmed by patient history, physical examination, and radiographic evaluation with one or more of the following factors: Greater than 2mm of decreased disc
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