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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 1 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	214-2008	FDA UDI	Class II	Active
OsteoMed	214-2040	FDA UDI	Class II	Active
OsteoMed	213-0021	FDA UDI	Class II	Active
OsteoMed	316-1709-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2900	FDA UDI	Class II	Active
OsteoMed	316-0313	FDA UDI	Class II	Active
OsteoMed	218-1605	FDA UDI	Class II	Active
OsteoMed	220-0423	FDA UDI	Class I	Active
OsteoMed	319-7100-SP	FDA UDI	Class II	Active
OsteoMed	337-3580	FDA UDI	Class II	Active
OsteoMed	450-0032	FDA UDI	Class II	Active
OsteoMed	319-5524-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1022	FDA UDI	Class II	Active
OsteoMed	331-2032	FDA UDI	Class II	Active
OsteoMed	813-0745-SP	FDA UDI	Class II	Unknown
OsteoMed	308-3036-SP	FDA UDI	Class II	Active
OsteoMed	324-1290	FDA UDI	Class II	Active
OsteoMed	317-2442-SP-05	FDA UDI	Class II	Active
OsteoMed	308-1614-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-86	FDA UDI	Class II	Active
OsteoMed	811-1008	FDA UDI	Class II	Unknown
OsteoMed	339-5550-SP-02	FDA UDI	Class II	Active
OsteoMed	231-1051	FDA UDI	Class II	Active
OsteoMed	323-4002	FDA UDI	Class II	Active
OsteoMed	320-2711	FDA UDI	Class II	Active
OsteoMed	220-0640-16	FDA UDI	Class II	Active
OsteoMed	343-2724	FDA UDI	Class II	Active
OsteoMed	320-1213	FDA UDI	Class II	Active
OsteoMed	319-2414	FDA UDI	Class II	Active
OsteoMed	354-1808	FDA UDI	Class II	Active
OsteoMed	816-1760-SP	FDA UDI	Class II	Unknown
OsteoMed	210-0016-SP	FDA UDI	Class II	Active
OsteoMed	339-5544	FDA UDI	Class II	Active
OsteoMed	331-2034-SP-02	FDA UDI	Class II	Active
OsteoMed	330-1818	FDA UDI	Class II	Active
OsteoMed	341-1008	FDA UDI	Class II	Active
OsteoMed	211-1605-SP-10	FDA UDI	Class II	Active
OsteoMed	213-1677	FDA UDI	Class II	Active
OsteoMed	214-2039	FDA UDI	Class II	Active
OsteoMed	338-4044	FDA UDI	Class II	Active
OsteoMed	320-1050	FDA UDI	Class II	Active
OsteoMed	317-2420	FDA UDI	Class II	Active
OsteoMed	220-0643-30	FDA UDI	Class II	Active
OsteoMed	220-0703	FDA UDI	Class II	Active
OsteoMed	214-2025	FDA UDI	Class II	Active
OsteoMed	317-5530	FDA UDI	Class II	Active
OsteoMed	345-5560	FDA UDI	Class II	Active
OsteoMed	354-1834-SP-05	FDA UDI	Class II	Active
OsteoMed	336-9104	FDA UDI	Class II	Active
OsteoMed	358-2715-SP-05	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.