Data / Medical devices / France / Serf
Serf: FDA-registered device maker in DECINES CHARPIEU Rhone, France, 5 510(k) clearances
Serf is registered with the FDA (registration 3008668801) in DECINES CHARPIEU Rhone, France. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 25, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008668801
- Address
- 85 Avenue des Bruyeres, DECINES CHARPIEU Rhone, France, 69150
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 29, 1992
- Registered through
- 2027
- Brand names listed
- 10mm SUBFIX TRIAL, 11.5mm SUBFIX TRIAL, 206-716 w/2 small sculps/pkg, 3MM DBL SLEEVE 80MM TROC/ASSY, 3mm PREDRILL ASSEMBLY LONG, 3mm PREDRILL ASSEMBLY SHORT, 4MM DBL SLVE 180MM TROC/ASSY, 4mm DBL SLEEVE 150mm TROC/ASSY and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 25, 2025 | K250989 | Stryker and Serf hip devices | LPH | Substantially Equivalent | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | accessdata.fda.gov |
| December 22, 2023 | K223745 | Novae® Dual Mobility System, Hype® Hip System | LZO | Substantially Equivalent | Serf | accessdata.fda.gov |
| December 11, 2018 | K181744 | BI-MENTUM dual mobility system | LZO | Substantially Equivalent | Serf | accessdata.fda.gov |
| January 15, 2015 | K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | LZO | Substantially Equivalent | Serf | accessdata.fda.gov |
| August 29, 2011 | K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL | LZO | Substantially Equivalent | Serf | accessdata.fda.gov |
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Updated July 25, 2025. 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.