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Osteomed Corp.

Last updated September 17, 2026

What Osteomed Corp. makes

Osteomed Corp. manufactures non-bioabsorbable orthopaedic hardware, including sterile and non-sterile bone screws for general internal fixation, craniofacial fixation plates and screws, and reusable instrument trays for surgical procedures. Their products are designed for skeletal stabilization in orthopaedic and craniofacial applications, such as fracture fixation and bone alignment. The company also supplies orthopaedic fixation system implantation kits for surgical use.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to domestic regulatory requirements for medical device authorization.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Osteomed Corp. manufacture?

Osteomed Corp. specializes in non-bioabsorbable orthopaedic hardware. Their product range includes bone screws (both sterile and non-sterile) for general internal fixation, craniofacial fixation plates and screws, orthopaedic fixation plates, and reusable instrument trays. These devices are primarily used for skeletal stabilization in orthopaedic and craniofacial surgeries, such as fracture fixation and bone alignment.

Where is Osteomed Corp. based, and how does this affect their regulatory compliance?

Osteomed Corp. is based in the United States. Since they operate domestically, their devices must comply with FDA regulations, including classification under FDA’s device classification system (Class I or Class II) and listing in the FDA’s Unique Device Identification (UDI) system. This ensures their products meet U.S. requirements for safety and effectiveness before authorization.

Which regulatory registries or databases list Osteomed Corp.’s devices?

Osteomed Corp.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency for each authorized product, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices in use.

How are Osteomed Corp.’s devices classified under FDA regulations?

Osteomed Corp.’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and performance. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.

What distinguishes Osteomed Corp.’s orthopaedic fixation systems from other similar products?

Osteomed Corp.’s orthopaedic fixation systems are designed for non-bioabsorbable skeletal stabilization, meaning they remain in the body long-term to support bone healing. Their portfolio includes both standalone components (like screws and plates) and complete implantation kits, which streamline surgical procedures. The company’s devices are tailored for general orthopaedic and craniofacial applications, ensuring compatibility with a range of medical needs while adhering to FDA authorization requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 3885 Arapaho Rd, ADDISON, TX, 75001
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2027754
DUNS Number: —

Catalogue (8033)

Page 30 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	206-2406-SP-05	FDA UDI	Class II	Active
OsteoMed	380-0011	FDA UDI	Class II	Active
OsteoMed	319-6080	FDA UDI	Class II	Active
OsteoMed	815-0930-SP	FDA UDI	Class II	Unknown
OsteoMed	810-2001	FDA UDI	Class II	Unknown
OsteoMed	319-4522-SP-02	FDA UDI	Class II	Active
OsteoMed	323-1820	FDA UDI	Class II	Active
OsteoMed	450-0240	FDA UDI	Class II	Active
OsteoMed	220-0121	FDA UDI	Class II	Active
OsteoMed	216-0305	FDA UDI	Class II	Active
OsteoMed	339-4550-SP-02	FDA UDI	Class II	Active
OsteoMed	336-5209	FDA UDI	Class II	Active
OsteoMed	813-1135-SP	FDA UDI	Class II	Unknown
OsteoMed	800-0115-SP	FDA UDI	Class II	Unknown
OsteoMed	451-2054-SP	FDA UDI	Class II	Active
OsteoMed	316-0049	FDA UDI	Class II	Active
OsteoMed	210-0022	FDA UDI	Class II	Active
OsteoMed	359-2410	FDA UDI	Class II	Active
OsteoMed	317-2438-SP-05	FDA UDI	Class II	Active
OsteoMed	385-0050	FDA UDI	Class II	Active
OsteoMed	343-2726	FDA UDI	Class II	Active
OsteoMed	218-0030-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0801-03	FDA UDI	Class II	Active
OsteoMed	220-0560	FDA UDI	Class II	Active
OsteoMed	319-6065-SP	FDA UDI	Class II	Active
OsteoMed	321-3545-SP-02	FDA UDI	Class II	Active
OsteoMed	317-0815	FDA UDI	Class II	Active
OsteoMed	319-2407-SP-05	FDA UDI	Class II	Active
OsteoMed	333-1203	FDA UDI	Class II	Active
OsteoMed	318-4024	FDA UDI	Class II	Active
OsteoMed	336-2744	FDA UDI	Class II	Active
OsteoMed	386-1021	FDA UDI	Class II	Active
OsteoMed	319-6110-SP	FDA UDI	Class II	Active
OsteoMed	214-0055	FDA UDI	Class II	Active
OsteoMed	210-0206	FDA UDI	Class II	Active
OsteoMed	338-4090	FDA UDI	Class II	Active
OsteoMed	208-1906	FDA UDI	Class II	Active
OsteoMed	320-2415	FDA UDI	Class II	Active
OsteoMed	220-0613-00	FDA UDI	Class II	Active
OsteoMed	316-0920	FDA UDI	Class II	Active
OsteoMed	814-1013	FDA UDI	Class II	Unknown
OsteoMed	333-2013	FDA UDI	Class II	Active
OsteoMed	220-0604	FDA UDI	Class II	Active
OsteoMed	450-5713-SP	FDA UDI	Class II	Active
OsteoMed	320-2030-SP-02	FDA UDI	Class II	Active
OsteoMed	319-4022-SP-05	FDA UDI	Class II	Active
OsteoMed	339-5570-SP-02	FDA UDI	Class II	Active
OsteoMed	288-0036	FDA UDI	Class I	Active
OsteoMed	317-0805	FDA UDI	Class II	Active
OsteoMed	315-4014	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Osteomed Corp. has 15 recall records initiated between April 2, 2020, and May 31, 2023, with statuses recorded as open, classified, or terminated. The reasons cited include non-compliance with electrical safety standards (IEC 60601) for consoles, undersized screwheads in osteotomy screws, and incorrect shelf-life labeling for bone void filler kits, which may affect product performance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 31, 2023	Z-2107-2023	—	open, classified	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
May 31, 2023	Z-2108-2023	—	open, classified	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Oct 28, 2021	Z-0335-2022	—	open, classified	Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Apr 2, 2020	Z-2184-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2185-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2191-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2190-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2186-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2188-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2189-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2187-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2180-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2182-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2181-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Apr 2, 2020	Z-2183-2020	—	terminated	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.