Normed Medizin-Technik GmbH
Country not established
- Devices
- 10
What Normed Medizin-Technik GmbH makes
Normed Medizin-Technik GmbH manufactures orthopedic fixation systems for lower limb and foot surgeries, including ankle stabilization devices (NORMED ANKLE FIX SYSTEM 4.0 and NORMED ANKLE FIX PLUS SYSTEM 4.0), compression screws, and titanium miniplates for bone stabilization. Their portfolio also includes specialized screws (Tenodesis, Pellegrini calcaneus stop) and modular plate-and-screw systems for midfoot and hindfoot reconstruction (RECON system variants).
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
RECON system Ref K151407
Regimes: 510(k) Registry: 510(k)Normed Titanium Miniplate System Ref K931539
Regimes: 510(k) Registry: 510(k)Normed Vario Subtalar Screw Ref K140962
Regimes: 510(k) Registry: 510(k)Tenodesis screw system Ref K151701
Regimes: 510(k) Registry: 510(k)Normed Pellegrin Calcaneus Stop Screw Ref K133035
Regimes: 510(k) Registry: 510(k)RECON system - Compression Screws Ref K151708
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
RECON system-V-TEK-IVP Plates and Screws Ref K152312
Regimes: 510(k) Registry: 510(k)RECON system - MPJ-Plates Ref K152142
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Normed Medizin-Technik GmbH have in the registry?
The registry currently lists 10 devices for Normed Medizin-Technik GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Normed Medizin-Technik GmbH's devices?
Among its 10 most recently registered devices, Normed Medizin-Technik GmbH has devices listed in FDA 510(k) (10 devices).
What risk classes do Normed Medizin-Technik GmbH's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Normed Medizin-Technik GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Normed Medizin-Technik GmbH in the registry?
The most recently registered devices listed for Normed Medizin-Technik GmbH include NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0, RECON system, NORMED TITANIUM MINIPLATE SYSTEM and NORMED VARIO SUBTALAR SCREW.