Osteomed LP
United StatesFDA applicant, unverified
- Devices
- 29
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Osteomed LP makes
Osteomed LP manufactures orthopedic and maxillofacial fixation devices, including headless cannulated screws, hand fusion systems, mandibular distraction systems for pediatric patients, metatarsal resurfacing implants, subtalar implants, and modular locking fixation hardware. Their portfolio also includes lateral lumbar interbody fusion units made from PEEK, condylar attachment systems, calcaneal fixation plates and screws, and articulated locking plates for bone stabilization.
The company’s devices are classified under FDA Class II and Class U, with submissions recorded in the FDA’s 510(k) registry. Products are designed for spinal, lower extremity, and facial bone applications, adhering to U.S. regulatory requirements for medical devices.
Catalogue
Search and filter all 29 devicesFDA recalls
FDA recall records list 1 recall initiated by Osteomed LP, initiated on 2011-06-07. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 7 Jun 2011 Z-0008-2012 Unclassified (pre-2012) Terminated Two of the Implant Driver Assembly tips were reported to break during surgery.
Frequently asked questions
How many devices does Osteomed LP have in the registry?
The registry currently lists 29 devices for Osteomed LP. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteomed LP's devices?
Among its 29 most recently registered devices, Osteomed LP has devices listed in FDA 510(k) (29 devices).
What risk classes do Osteomed LP's devices fall under?
Among its 29 most recently registered devices, the classes recorded for Osteomed LP's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Osteomed LP?
FDA recall records list 1 recall initiated by Osteomed LP, the most recent initiated on 7 Jun 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Osteomed LP in the registry?
The most recently registered devices listed for Osteomed LP include OSTEOMED HEADLESS CANNULATED SCREW SYSTEM, OSTEOMED HAND FUSION SYSTEM, OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED and OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM.