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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 19 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	218-0053	FDA UDI	Class II	Active
OsteoMed	336-9002	FDA UDI	Class II	Active
OsteoMed	323-1935	FDA UDI	Class II	Active
OsteoMed	333-2007	FDA UDI	Class II	Active
OsteoMed	3552	FDA UDI	U	Active
OsteoMed	319-4538	FDA UDI	Class II	Active
OsteoMed	333-1604	FDA UDI	Class II	Active
OsteoMed	386-1012	FDA UDI	Class II	Active
OsteoMed	319-5530-SP-02	FDA UDI	Class II	Active
OsteoMed	317-6576	FDA UDI	Class II	Active
OsteoMed	316-0311	FDA UDI	Class II	Active
OsteoMed	342-2730-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0132	FDA UDI	Class II	Active
OsteoMed	333-2404-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0322	FDA UDI	Class II	Active
OsteoMed	208-1610	FDA UDI	Class II	Active
OsteoMed	336-2740-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0214	FDA UDI	Class II	Active
OsteoMed	319-0024-SP-05	FDA UDI	Class II	Active
OsteoMed	330-2026-SP-05	FDA UDI	Class II	Active
OsteoMed	3553-S	FDA UDI	U	Active
OsteoMed	323-1703	FDA UDI	Class II	Active
OsteoMed	111-1261	FDA UDI	Class II	Active
OsteoMed	213-0028	FDA UDI	Class II	Active
OsteoMed	333-1207	FDA UDI	Class II	Active
OsteoMed	330-2434	FDA UDI	Class II	Active
OsteoMed	337-3542-SP-02	FDA UDI	Class II	Active
OsteoMed	810-4001	FDA UDI	Class II	Unknown
OsteoMed	320-6112	FDA UDI	Class II	Active
OsteoMed	324-1251-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2780	FDA UDI	Class II	Active
OsteoMed	220-0640-81	FDA UDI	Class II	Active
OsteoMed	337-3526-SP-02	FDA UDI	Class II	Active
OsteoMed	341-0002	FDA UDI	Class II	Active
OsteoMed	816-1535-SP	FDA UDI	Class II	Unknown
OsteoMed	814-0760-SP	FDA UDI	Class II	Unknown
OsteoMed	319-0750-SP-02	FDA UDI	Class II	Active
OsteoMed	400-3703-SP	FDA UDI	Class II	Active
OsteoMed	320-3504	FDA UDI	Class II	Active
OsteoMed	339-6580	FDA UDI	Class II	Active
OsteoMed	339-5526	FDA UDI	Class II	Active
OsteoMed	450-0435	FDA UDI	Class II	Active
OsteoMed	450-2013	FDA UDI	Class II	Active
OsteoMed	218-3165-SP	FDA UDI	Class II	Active
OsteoMed	318-3022	FDA UDI	Class II	Active
OsteoMed	213-1681	FDA UDI	Class II	Active
OsteoMed	218-3150-SP	FDA UDI	Class II	Active
OsteoMed	817-0960-SP	FDA UDI	Class II	Unknown
OsteoMed	323-1408	FDA UDI	Class II	Active
OsteoMed	220-0644-60	FDA UDI	Class II	Active

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Authorities

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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.