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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 29 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	204-1214-SP-05	FDA UDI	Class II	Active
OsteoMed	222-0007	FDA UDI	Class II	Active
OsteoMed	234-2020	FDA UDI	Class II	Active
OsteoMed	323-4002-01	FDA UDI	Class II	Active
OsteoMed	813-1755-SP	FDA UDI	Class II	Unknown
OsteoMed	323-1235	FDA UDI	Class II	Active
OsteoMed	210-0076	FDA UDI	Class II	Active
OsteoMed	315-4028	FDA UDI	Class II	Active
OsteoMed	345-5530	FDA UDI	Class II	Active
OsteoMed	817-1011	FDA UDI	Class II	Unknown
OsteoMed	210-0206-SP	FDA UDI	Class II	Active
OsteoMed	355-0601-SP-05	FDA UDI	Class II	Active
OsteoMed	202-0001	FDA UDI	Class II	Active
OsteoMed	316-0009	FDA UDI	Class II	Active
OsteoMed	336-2700	FDA UDI	Class II	Active
OsteoMed	220-0597	FDA UDI	Class II	Active
OsteoMed	332-1218	FDA UDI	Class II	Active
OsteoMed	342-2714-SP-02	FDA UDI	Class II	Active
OsteoMed	331-1616-SP-05	FDA UDI	Class II	Active
OsteoMed	337-0008	FDA UDI	Class II	Active
OsteoMed	319-5555-SP-02	FDA UDI	Class II	Active
OsteoMed	319-4565-SP-02	FDA UDI	Class II	Active
OsteoMed	214-0400T	FDA UDI	Class II	Active
OsteoMed	359-2738	FDA UDI	Class II	Active
OsteoMed	354-1821-SP-02	FDA UDI	Class II	Active
OsteoMed	358-2413	FDA UDI	Class II	Active
OsteoMed	336-3563	FDA UDI	Class II	Active
OsteoMed	205-1607	FDA UDI	Class II	Active
OsteoMed	337-4050-SP-02	FDA UDI	Class II	Active
OsteoMed	204-1210	FDA UDI	Class II	Active
OsteoMed	317-5547-SP-02	FDA UDI	Class II	Active
OsteoMed	319-6620	FDA UDI	Class II	Active
OsteoMed	220-0640-88	FDA UDI	Class II	Active
OsteoMed	232-2016	FDA UDI	Class II	Active
OsteoMed	810-2005	FDA UDI	Class II	Unknown
OsteoMed	375-0006	FDA UDI	Class II	Active
OsteoMed	220-0840	FDA UDI	Class II	Active
OsteoMed	355-0306-SP-02	FDA UDI	Class II	Active
OsteoMed	349-2426-SP-05	FDA UDI	Class II	Active
OsteoMed	210-1021	FDA UDI	Class II	Active
OsteoMed	210-3015-SP	FDA UDI	Class II	Active
OsteoMed	319-3040	FDA UDI	Class II	Active
OsteoMed	345-4575	FDA UDI	Class II	Active
OsteoMed	317-6610-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4541-SP-02	FDA UDI	Class II	Active
OsteoMed	319-5580-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0326-SP-02	FDA UDI	Class II	Active
OsteoMed	450-2055	FDA UDI	Class II	Active
OsteoMed	231-1054T	FDA UDI	Class II	Active
OsteoMed	212-1664	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.