Data / Medical devices / Germany / Inkutec GMBH
Inkutec GMBH: FDA-registered device maker in Barsbüttel Schleswig-Holstein, Germany, 1 510(k) clearance
Inkutec GMBH is registered with the FDA (registration 3006846433) in Barsbüttel Schleswig-Holstein, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006846433
- Address
- Hanskampring 8, Barsbüttel Schleswig-Holstein, Germany, 22885
- Owner or operator
- INKUTEC GmbH (10043838)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 27, 2013
- Registered through
- 2026
- Brand names listed
- OLYMPUS STERILIZATION TRAYS, STERILIZATION TRAY DRAPELINK CRANIAL, Steritray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract 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 22, 2010 | K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES | HSB | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated December 22, 2010. 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.