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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 11 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	318-3016	FDA UDI	Class II	Active
OsteoMed	213-0127	FDA UDI	Class II	Active
OsteoMed	225-2318	FDA UDI	Class II	Active
OsteoMed	358-2418	FDA UDI	Class II	Active
OsteoMed	302-2028-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-20	FDA UDI	Class II	Active
OsteoMed	111-1260	FDA UDI	Class II	Active
OsteoMed	214-2414	FDA UDI	Class II	Active
OsteoMed	354-1809-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0215-SP-02	FDA UDI	Class II	Active
OsteoMed	817-1355-SP	FDA UDI	Class II	Unknown
OsteoMed	214-0092	FDA UDI	Class II	Active
OsteoMed	302-2014-SP	FDA UDI	Class II	Active
OsteoMed	308-1610	FDA UDI	Class II	Active
OsteoMed	339-4052	FDA UDI	Class II	Active
OsteoMed	450-0301	FDA UDI	Class II	Active
OsteoMed	319-6611-SP-02	FDA UDI	Class II	Active
OsteoMed	400-3709-SP	FDA UDI	Class II	Active
OsteoMed	345-6570	FDA UDI	Class II	Active
OsteoMed	220-0644-69	FDA UDI	Class II	Active
OsteoMed	337-4058	FDA UDI	Class II	Active
OsteoMed	323-2418	FDA UDI	Class I	Active
OsteoMed	319-0791-SP-02	FDA UDI	Class II	Active
OsteoMed	319-4566	FDA UDI	Class II	Active
OsteoMed	220-0641-45	FDA UDI	Class II	Active
OsteoMed	220-0643-36	FDA UDI	Class II	Active
OsteoMed	319-7075-SP	FDA UDI	Class II	Active
OsteoMed	336-2723-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0059-SP-02	FDA UDI	Class II	Active
OsteoMed	212-0036-SP-05	FDA UDI	Class II	Active
OsteoMed	319-7045-SP	FDA UDI	Class II	Active
OsteoMed	213-0062	FDA UDI	Class II	Active
OsteoMed	317-4030-SP-05	FDA UDI	Class II	Active
OsteoMed	354-1824-SP-02	FDA UDI	Class II	Active
OsteoMed	302-2009	FDA UDI	Class II	Active
OsteoMed	214-2419	FDA UDI	Class II	Active
OsteoMed	210-0110-SP	FDA UDI	Class II	Active
OsteoMed	316-0920-SP-02	FDA UDI	Class II	Active
OsteoMed	337-4070	FDA UDI	Class II	Active
OsteoMed	319-6601	FDA UDI	Class II	Active
OsteoMed	214-2011	FDA UDI	Class II	Active
OsteoMed	320-0382	FDA UDI	Class II	Active
OsteoMed	220-0852	FDA UDI	Class II	Active
OsteoMed	305-3530	FDA UDI	Class II	Active
OsteoMed	213-0006-SP-02	FDA UDI	Class II	Active
OsteoMed	336-5113-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-34	FDA UDI	Class II	Active
OsteoMed	211-1606	FDA UDI	Class II	Active
OsteoMed	319-2406-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0644-90	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.