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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 3 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	336-2217-SP-02	FDA UDI	Class II	Active
OsteoMed	321-4028-SP-02	FDA UDI	Class II	Active
OsteoMed	336-2210	FDA UDI	Class II	Active
OsteoMed	800-1125-SP	FDA UDI	U	Unknown
OsteoMed	337-4050	FDA UDI	Class II	Active
OsteoMed	220-0312	FDA UDI	Class II	Active
OsteoMed	319-7121-SP-02	FDA UDI	Class II	Active
OsteoMed	214-2051-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0111-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-148	FDA UDI	Class II	Active
OsteoMed	338-3524	FDA UDI	Class II	Active
OsteoMed	336-2772	FDA UDI	Class II	Active
OsteoMed	213-0126	FDA UDI	Class II	Active
OsteoMed	308-1620-SP-05	FDA UDI	Class II	Active
OsteoMed	233-2005	FDA UDI	Class II	Active
OsteoMed	336-0007-SP-02	FDA UDI	Class II	Active
OsteoMed	321-2745	FDA UDI	Class II	Active
OsteoMed	319-6111-SP	FDA UDI	Class II	Active
OsteoMed	319-7095-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2216	FDA UDI	Class II	Active
OsteoMed	318-3028	FDA UDI	Class II	Active
OsteoMed	358-2408-SP-02	FDA UDI	Class II	Active
OsteoMed	336-4008-SP-02	FDA UDI	Class II	Active
OsteoMed	322-2710-SP-05	FDA UDI	Class II	Active
OsteoMed	231-1532T	FDA UDI	Class II	Active
OsteoMed	211-2006-SP-06	FDA UDI	Class II	Active
OsteoMed	322-4050-SP-02	FDA UDI	Class II	Active
OsteoMed	336-6005-SP-02	FDA UDI	Class II	Active
OsteoMed	322-4040-SP-02	FDA UDI	Class II	Active
OsteoMed	204-1506-SP-02	FDA UDI	Class II	Active
OsteoMed	310-2144	FDA UDI	Class II	Active
OsteoMed	212-1682	FDA UDI	Class II	Active
OsteoMed	319-2022-SP-05	FDA UDI	Class II	Active
OsteoMed	234-2014	FDA UDI	Class II	Active
OsteoMed	815-1155-SP	FDA UDI	Class II	Unknown
OsteoMed	218-0201	FDA UDI	Class II	Active
OsteoMed	324-1031	FDA UDI	Class II	Active
OsteoMed	220-0643-86	FDA UDI	Class II	Active
OsteoMed	321-3512	FDA UDI	Class II	Active
OsteoMed	390-8505	FDA UDI	Class II	Active
OsteoMed	220-0640-105	FDA UDI	Class II	Active
OsteoMed	342-2712-SP-02	FDA UDI	Class II	Active
OsteoMed	333-2053	FDA UDI	Class II	Active
OsteoMed	321-3538	FDA UDI	Class II	Active
OsteoMed	336-5102	FDA UDI	Class II	Active
OsteoMed	320-2030	FDA UDI	Class II	Active
OsteoMed	220-0643-31	FDA UDI	Class II	Active
OsteoMed	324-1001-SP-02	FDA UDI	Class II	Active
OsteoMed	810-0024	FDA UDI	Class II	Unknown
OsteoMed	220-0643-64	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.