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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 24 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	210-0404	FDA UDI	Class II	Active
OsteoMed	355-0107-SP-02	FDA UDI	Class II	Active
OsteoMed	210-1020	FDA UDI	Class II	Active
OsteoMed	339-5524-SP-02	FDA UDI	Class II	Active
OsteoMed	323-2422	FDA UDI	Class I	Active
OsteoMed	218-3170-SP	FDA UDI	Class II	Active
OsteoMed	319-0786	FDA UDI	Class II	Active
OsteoMed	339-5580	FDA UDI	Class II	Active
OsteoMed	338-4110-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-116	FDA UDI	Class II	Active
OsteoMed	339-4048-SP-02	FDA UDI	Class II	Active
OsteoMed	214-0202	FDA UDI	Class II	Active
OsteoMed	319-7065	FDA UDI	Class II	Active
OsteoMed	336-3564-SP-02	FDA UDI	Class II	Active
OsteoMed	339-5575-SP-02	FDA UDI	Class II	Active
OsteoMed	320-1015	FDA UDI	Class II	Active
OsteoMed	813-1540-SP	FDA UDI	Class II	Unknown
OsteoMed	812-1140-SP	FDA UDI	Class II	Unknown
OsteoMed	315-4034	FDA UDI	Class II	Active
OsteoMed	204-1208-SP-10	FDA UDI	Class II	Active
OsteoMed	342-2728	FDA UDI	Class II	Active
OsteoMed	338-4020	FDA UDI	Class II	Active
OsteoMed	317-3036-SP-05	FDA UDI	Class II	Active
OsteoMed	110-1001	FDA UDI	Class II	Active
OsteoMed	220-0640-126	FDA UDI	Class II	Active
OsteoMed	319-0811	FDA UDI	Class II	Active
OsteoMed	211-2005-SP-06	FDA UDI	Class II	Active
OsteoMed	330-2411	FDA UDI	Class II	Active
OsteoMed	218-0026-SP	FDA UDI	Class II	Active
OsteoMed	450-0619	FDA UDI	Class I	Active
OsteoMed	323-1520	FDA UDI	Class II	Active
OsteoMed	450-6140-SP	FDA UDI	Class II	Active
OsteoMed	220-0524	FDA UDI	Class II	Active
OsteoMed	214-2401	FDA UDI	Class II	Active
OsteoMed	358-2436	FDA UDI	Class II	Active
OsteoMed	450-2232	FDA UDI	Class II	Active
OsteoMed	333-2012-SP-02	FDA UDI	Class II	Active
OsteoMed	319-4052-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0622	FDA UDI	Class II	Active
OsteoMed	210-0014T	FDA UDI	Class II	Active
OsteoMed	333-1601	FDA UDI	Class II	Active
OsteoMed	336-7203	FDA UDI	Class II	Active
OsteoMed	319-4536-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2401	FDA UDI	Class II	Active
OsteoMed	400-1115-SP	FDA UDI	Class II	Active
OsteoMed	375-0002	FDA UDI	Class II	Active
OsteoMed	317-6565	FDA UDI	Class II	Active
OsteoMed	318-3024	FDA UDI	Class II	Active
OsteoMed	313-3522	FDA UDI	Class II	Active
OsteoMed	214-2026	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.