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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 6 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	220-0644-61	FDA UDI	Class II	Active
OsteoMed	341-1007	FDA UDI	Class II	Active
OsteoMed	400-1120-SP	FDA UDI	Class II	Active
OsteoMed	114-2051	FDA UDI	Class I	Active
OsteoMed	339-4522-SP-02	FDA UDI	Class II	Active
OsteoMed	324-3006-SP-01	FDA UDI	Class II	Active
OsteoMed	324-1220-SP-05	FDA UDI	Class II	Active
OsteoMed	317-2434-SP-05	FDA UDI	Class II	Active
OsteoMed	224-0034	FDA UDI	Class II	Active
OsteoMed	450-0216	FDA UDI	Class II	Active
OsteoMed	220-0641-71	FDA UDI	Class II	Active
OsteoMed	220-0643-43	FDA UDI	Class II	Active
OsteoMed	214-0094	FDA UDI	Class II	Active
OsteoMed	218-2007	FDA UDI	Class II	Active
OsteoMed	213-0064	FDA UDI	Class II	Active
OsteoMed	450-0502	FDA UDI	Class II	Active
OsteoMed	317-6540	FDA UDI	Class II	Active
OsteoMed	354-1813-SP-02	FDA UDI	Class II	Active
OsteoMed	322-3528-SP-02	FDA UDI	Class II	Active
OsteoMed	345-5570	FDA UDI	Class II	Active
OsteoMed	202-2006	FDA UDI	Class II	Active
OsteoMed	217-1604	FDA UDI	Class II	Active
OsteoMed	319-6620-SP-02	FDA UDI	Class II	Active
OsteoMed	208-1908-SP-02	FDA UDI	Class II	Active
OsteoMed	319-0745-SP-02	FDA UDI	Class II	Active
OsteoMed	317-5541-SP-02	FDA UDI	Class II	Active
OsteoMed	301-2016	FDA UDI	Class II	Active
OsteoMed	212-1692	FDA UDI	Class II	Active
OsteoMed	220-0500	FDA UDI	Class II	Active
OsteoMed	354-1813	FDA UDI	Class II	Active
OsteoMed	317-0796	FDA UDI	Class II	Active
OsteoMed	450-1007	FDA UDI	Class II	Active
OsteoMed	320-2924-09	FDA UDI	Class II	Active
OsteoMed	336-6211	FDA UDI	Class II	Active
OsteoMed	319-5544	FDA UDI	Class II	Active
OsteoMed	212-0148	FDA UDI	Class II	Active
OsteoMed	359-2714-SP-05	FDA UDI	Class II	Active
OsteoMed	210-0149-SP	FDA UDI	Class II	Active
OsteoMed	815-1560-SP	FDA UDI	Class II	Unknown
OsteoMed	319-0760	FDA UDI	Class II	Active
OsteoMed	317-6551	FDA UDI	Class II	Active
OsteoMed	316-1902	FDA UDI	Class II	Active
OsteoMed	316-0122	FDA UDI	Class II	Active
OsteoMed	202-2305	FDA UDI	Class II	Active
OsteoMed	317-5575	FDA UDI	Class II	Active
OsteoMed	317-4547	FDA UDI	Class II	Active
OsteoMed	336-4008	FDA UDI	Class II	Active
OsteoMed	324-1030	FDA UDI	Class II	Active
OsteoMed	323-1702	FDA UDI	Class II	Active
OsteoMed	214-0401	FDA UDI	Class II	Active

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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.