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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 17 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	213-1600	FDA UDI	Class II	Active
OsteoMed	222-0005	FDA UDI	Class II	Active
OsteoMed	338-2712-SP-05	FDA UDI	Class II	Active
OsteoMed	349-2424-SP-02	FDA UDI	Class II	Active
OsteoMed	336-3528-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0205-SP-05	FDA UDI	Class II	Active
OsteoMed	360-2240	FDA UDI	Class II	Active
OsteoMed	316-0516	FDA UDI	Class I	Active
OsteoMed	316-0321	FDA UDI	Class II	Active
OsteoMed	450-0285	FDA UDI	Class II	Active
OsteoMed	218-0079-SP	FDA UDI	Class II	Active
OsteoMed	320-1213-SP-02	FDA UDI	Class II	Active
OsteoMed	208-1608-SP-10	FDA UDI	Class II	Active
OsteoMed	321-9002	FDA UDI	Class II	Active
OsteoMed	331-2006-SP-05	FDA UDI	Class II	Active
OsteoMed	338-3555-SP-02	FDA UDI	Class II	Active
OsteoMed	333-1208-SP-02	FDA UDI	Class II	Active
OsteoMed	218-1604-SP-10	FDA UDI	Class II	Active
OsteoMed	231-2001	FDA UDI	Class II	Active
OsteoMed	450-0380	FDA UDI	Class II	Active
OsteoMed	211-1203-SP	FDA UDI	Class II	Active
OsteoMed	450-3166-SP	FDA UDI	Class II	Unknown
OsteoMed	359-2730-SP-05	FDA UDI	Class II	Active
OsteoMed	338-3546-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0641-70	FDA UDI	Class II	Active
OsteoMed	214-2010	FDA UDI	Class II	Active
OsteoMed	220-0508	FDA UDI	Class II	Active
OsteoMed	316-0006	FDA UDI	Class II	Active
OsteoMed	358-2713	FDA UDI	Class II	Active
OsteoMed	359-2420	FDA UDI	Class II	Active
OsteoMed	334-2018-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1285-SP-02	FDA UDI	Class II	Active
OsteoMed	450-0555	FDA UDI	Class II	Active
OsteoMed	319-5543-SP-02	FDA UDI	Class II	Active
OsteoMed	225-2004	FDA UDI	Class II	Active
OsteoMed	355-0601-SP	FDA UDI	Class II	Active
OsteoMed	343-2722-SP-02	FDA UDI	Class II	Active
OsteoMed	323-1301-SP-02	FDA UDI	Class II	Active
OsteoMed	339-4544-SP-02	FDA UDI	Class II	Active
OsteoMed	321-2710-SP-05	FDA UDI	Class II	Active
OsteoMed	308-1611-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0641-33	FDA UDI	Class II	Active
OsteoMed	324-1287	FDA UDI	Class II	Active
OsteoMed	817-1155-SP	FDA UDI	Class II	Unknown
OsteoMed	811-0014	FDA UDI	Class II	Unknown
OsteoMed	232-2420	FDA UDI	Class II	Active
OsteoMed	333-2453	FDA UDI	Class II	Active
OsteoMed	324-2252-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-16	FDA UDI	Class II	Active
OsteoMed	320-1018	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.