Data / Medical devices / France / Alpes CN SAS
Alpes CN SAS: FDA-registered device maker in Reignier-Esery Haute-Savoie, France, 3 510(k) clearances
Alpes CN SAS is registered with the FDA (registration 3037407500) in Reignier-Esery Haute-Savoie, France. It lists 49 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 14, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3037407500
- Address
- 356 Rue de la Tour, Reignier-Esery Haute-Savoie, France, 74930
- Owner or operator
- SPINEART SA (10028947)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 24, 2009
- Registered through
- 2027
- Brand names listed
- BAGUERA C, BENDER (all ranges), BIT, DRILL (all ranges), Bone taps ROMEO2 (multiple), CRIMPER, PIN (all ranges), CURE ACP 2, CURETTE, SURGICAL, GENERAL USE (all ranges), CURE ACP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Exporter to the US | accessdata.fda.gov |
| Bender | HXW | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Exporter to the US | accessdata.fda.gov |
| Bone Cement, Posterior Screw Augmentation | PML | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Crimper, Pin | HXQ | 1 | Exporter to the US | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Cement | KIH | 1 | Exporter to the US | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Exporter to the US | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Exporter to the US | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Exporter to the US | accessdata.fda.gov |
| Extractor | HWB | 1 | Exporter to the US | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Fork | HXE | 1 | Exporter to the US | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Exporter to the US | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Exporter to the US | accessdata.fda.gov |
| Impactor | HWA | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Contract manufacturer | accessdata.fda.gov |
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | 2 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Contract manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Exporter to the US | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Exporter to the US | accessdata.fda.gov |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | 2 | Contract manufacturer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Contract manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Intervertebral Disc | MJO | 3 | Contract manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Exporter to the US | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Exporter to the US | accessdata.fda.gov |
| Reamer | HTO | 1 | Exporter to the US | accessdata.fda.gov |
| Retractor | GAD | 1 | Exporter to the US | accessdata.fda.gov |
| Rongeur | HTX | 1 | Exporter to the US | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Contract manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Exporter to the US | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Template | HWT | 1 | Exporter to the US | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Wrench | HXC | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 14, 2026 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments | QLQ | Substantially Equivalent | Spineart SA | accessdata.fda.gov |
| May 1, 2026 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | Substantially Equivalent | Spineart SA | accessdata.fda.gov |
| January 6, 2016 | K151104 | OTELO LL | GAD | Substantially Equivalent | Spineart | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.