Data / Medical devices / France / Teknimed SAS
Teknimed SAS: FDA-registered device maker in L Union Haute-Garonne, France, 10 510(k) clearances
Teknimed SAS is registered with the FDA (registration 9615788) in L Union Haute-Garonne, France. It lists 14 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 18, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9615788
- FEI number
- 3003854593
- Address
- 11_12 rue d Apollo, L Union Haute-Garonne, France, 31240
- Owner or operator
- Teknimed (9040657)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 17, 2003
- Registered through
- 2026
- Brand names listed
- Dynamo Spinal cement System Gun MV, GENTAFIX (1 3 3MV), Max V Cement Mixing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Cement | LOD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bone Cement, Antibiotic | MBB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cement Obturator | LZN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 18, 2024 | K242216 | GENTAFIX® (1, 3, 3MV) | MBB | Substantially Equivalent | Teknimed Sas | accessdata.fda.gov |
| May 12, 2023 | K230394 | EUROSCREW NG; EUROSCREW TCP NG | MAI | Substantially Equivalent | Teknimed | accessdata.fda.gov |
| April 12, 2017 | K161114 | HIGH V+ | NDN | Substantially Equivalent | Teknimed Sas | accessdata.fda.gov |
| January 3, 2011 | K103433 | F20 | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| March 4, 2009 | K083005 | NANGEL | LYC | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| August 28, 2008 | K080873 | OPACITY + BONE CEMENT | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| March 17, 2006 | K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| May 3, 2004 | K040669 | CERAFORM BONE VOID FILLER | MQV | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| November 28, 2003 | K031826 | TRIHA + | MQV | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| November 26, 2003 | K032685 | CEMSTOP CEMENT RESTRICTOR | LZN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2022 | 91493 | Class II | Ongoing | HIGH V+ Spinal Cement System REF T040321K | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. | accessdata.fda.gov |
| August 31, 2006 | 36974 | Not yet classified | Terminated | OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc | The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box. | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver
- All makers of Device, Percutaneous, Biopsy
- All makers of Bone Cement, Antibiotic
- All makers of Bone Cement
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Spinal Channeling Instrument, Vertebroplasty
Updated December 18, 2024. 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.