Is this your brand? Sign in to claim ownership.

Osteomed Corp.

Last updated September 17, 2026

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 21 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	220-0643-62	FDA UDI	Class II	Active
OsteoMed	337-2720	FDA UDI	Class II	Active
OsteoMed	220-0307	FDA UDI	Class II	Active
OsteoMed	210-0214-SP	FDA UDI	Class II	Active
OsteoMed	349-2438-SP-05	FDA UDI	Class II	Active
OsteoMed	323-1422	FDA UDI	Class II	Active
OsteoMed	450-6003-SP	FDA UDI	Class II	Active
OsteoMed	336-4004	FDA UDI	Class II	Active
OsteoMed	304-1216	FDA UDI	Class II	Active
OsteoMed	336-2117	FDA UDI	Class II	Active
OsteoMed	359-2414-SP-02	FDA UDI	Class II	Active
OsteoMed	321-0123-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-29	FDA UDI	Class II	Active
OsteoMed	317-5549	FDA UDI	Class II	Active
OsteoMed	336-6213	FDA UDI	Class II	Active
OsteoMed	358-2419	FDA UDI	Class II	Active
OsteoMed	324-1267-SP-02	FDA UDI	Class II	Active
OsteoMed	336-0013	FDA UDI	Class II	Active
OsteoMed	455-3558	FDA UDI	Class II	Active
OsteoMed	322-4010	FDA UDI	Class II	Active
OsteoMed	214-0380	FDA UDI	Class II	Active
OsteoMed	359-2712-SP-05	FDA UDI	Class II	Active
OsteoMed	354-1840-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4052-SP-05	FDA UDI	Class II	Active
OsteoMed	318-2409	FDA UDI	Class II	Active
OsteoMed	218-0059-SP	FDA UDI	Class II	Active
OsteoMed	813-1130-SP	FDA UDI	Class II	Unknown
OsteoMed	310-4005	FDA UDI	Class II	Active
OsteoMed	359-2716-SP-05	FDA UDI	Class II	Active
OsteoMed	358-2718-SP-02	FDA UDI	Class II	Active
OsteoMed	323-1624	FDA UDI	Class II	Active
OsteoMed	322-2724	FDA UDI	Class II	Active
OsteoMed	324-2222	FDA UDI	Class II	Active
OsteoMed	358-2738-SP-02	FDA UDI	Class II	Active
OsteoMed	334-2432	FDA UDI	Class II	Active
OsteoMed	218-2002-SP	FDA UDI	Class II	Active
OsteoMed	319-6045-SP	FDA UDI	Class II	Active
OsteoMed	358-2418-SP-02	FDA UDI	Class II	Active
OsteoMed	355-0201-SP-02	FDA UDI	Class II	Active
OsteoMed	324-2242-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2724-SP-05	FDA UDI	Class II	Active
OsteoMed	455-3010	FDA UDI	Class II	Active
OsteoMed	220-0075	FDA UDI	Class II	Active
OsteoMed	220-0644-42	FDA UDI	Class II	Active
OsteoMed	450-2326-SP	FDA UDI	Class II	Active
OsteoMed	337-3538	FDA UDI	Class II	Active
OsteoMed	337-3522	FDA UDI	Class II	Active
OsteoMed	320-2035	FDA UDI	Class II	Active
OsteoMed	220-0705	FDA UDI	Class II	Active
OsteoMed	330-2013	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.

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.