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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 7 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	450-1619-SP	FDA UDI	Class II	Active
OsteoMed	319-7060-SP	FDA UDI	Class II	Active
OsteoMed	212-0031	FDA UDI	Class II	Active
OsteoMed	811-1002	FDA UDI	Class II	Unknown
OsteoMed	213-0200	FDA UDI	Class II	Active
OsteoMed	450-0718-SP	FDA UDI	Class II	Active
OsteoMed	450-0511	FDA UDI	Class II	Active
OsteoMed	336-3572	FDA UDI	Class II	Active
OsteoMed	206-2716-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0641-06	FDA UDI	Class II	Active
OsteoMed	213-1675	FDA UDI	Class II	Active
OsteoMed	814-1150-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0268	FDA UDI	Class II	Active
OsteoMed	321-3545	FDA UDI	Class II	Active
OsteoMed	323-1723	FDA UDI	Class II	Active
OsteoMed	336-7105-SP-02	FDA UDI	Class II	Active
OsteoMed	232-2010	FDA UDI	Class II	Active
OsteoMed	319-6075	FDA UDI	Class II	Active
OsteoMed	319-2412	FDA UDI	Class II	Active
OsteoMed	319-6606	FDA UDI	Class II	Active
OsteoMed	450-0207	FDA UDI	Class II	Active
OsteoMed	320-1021	FDA UDI	Class II	Active
OsteoMed	339-6610	FDA UDI	Class II	Active
OsteoMed	333-2421	FDA UDI	Class II	Active
OsteoMed	324-1020	FDA UDI	Class II	Active
OsteoMed	322-4050	FDA UDI	Class II	Active
OsteoMed	218-0026	FDA UDI	Class II	Active
OsteoMed	209-1910	FDA UDI	Class II	Active
OsteoMed	337-4018	FDA UDI	Class II	Active
OsteoMed	218-0060	FDA UDI	Class II	Active
OsteoMed	323-1416	FDA UDI	Class II	Active
OsteoMed	320-1210-SP-02	FDA UDI	Class II	Active
OsteoMed	816-1560-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0644-65	FDA UDI	Class II	Active
OsteoMed	220-0640-142	FDA UDI	Class II	Active
OsteoMed	220-0643-38	FDA UDI	Class II	Active
OsteoMed	218-0050	FDA UDI	Class II	Active
OsteoMed	322-4036	FDA UDI	Class II	Active
OsteoMed	375-0011	FDA UDI	Class II	Active
OsteoMed	324-2208	FDA UDI	Class II	Active
OsteoMed	450-1028-SP	FDA UDI	Class II	Active
OsteoMed	450-1028	FDA UDI	Class II	Active
OsteoMed	213-0123	FDA UDI	Class II	Active
OsteoMed	331-1212-SP-05	FDA UDI	Class II	Active
OsteoMed	354-1810-SP-02	FDA UDI	Class II	Active
OsteoMed	339-4016-SP-02	FDA UDI	Class II	Active
OsteoMed	322-3522-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-84	FDA UDI	Class II	Active
OsteoMed	220-0641-37	FDA UDI	Class II	Active
OsteoMed	316-0317-SP-02	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.