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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 26 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	354-1814-SP-05	FDA UDI	Class II	Active
OsteoMed	302-2018-SP	FDA UDI	Class II	Active
OsteoMed	220-0640-89	FDA UDI	Class II	Active
OsteoMed	210-1031-SP-05	FDA UDI	Class II	Active
OsteoMed	337-4095	FDA UDI	Class II	Active
OsteoMed	218-0075-SP	FDA UDI	Class II	Active
OsteoMed	220-1622	FDA UDI	Class II	Active
OsteoMed	339-4028-SP-02	FDA UDI	Class II	Active
OsteoMed	319-5540	FDA UDI	Class II	Active
OsteoMed	323-1701	FDA UDI	Class II	Active
OsteoMed	319-7090-SP-02	FDA UDI	Class II	Active
OsteoMed	214-0206-SP-02	FDA UDI	Class II	Active
OsteoMed	339-5548-SP-02	FDA UDI	Class II	Active
OsteoMed	303-1206	FDA UDI	Class II	Active
OsteoMed	455-6006	FDA UDI	Class II	Active
OsteoMed	337-2714-SP-05	FDA UDI	Class II	Active
OsteoMed	334-2420-SP-02	FDA UDI	Class II	Active
OsteoMed	319-6116-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-94	FDA UDI	Class II	Active
OsteoMed	220-0801-06	FDA UDI	Class II	Active
OsteoMed	231-2022	FDA UDI	Class II	Active
OsteoMed	210-0008-SP	FDA UDI	Class II	Active
OsteoMed	319-4555-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0643-18	FDA UDI	Class II	Active
OsteoMed	338-3532	FDA UDI	Class II	Active
OsteoMed	213-1612	FDA UDI	Class II	Active
OsteoMed	812-1530-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0231	FDA UDI	Class II	Active
OsteoMed	339-5536-SP-02	FDA UDI	Class II	Active
OsteoMed	812-0740-SP	FDA UDI	Class II	Unknown
OsteoMed	231-1051T	FDA UDI	Class II	Active
OsteoMed	218-2016-SP	FDA UDI	Class II	Active
OsteoMed	338-4060-SP-02	FDA UDI	Class II	Active
OsteoMed	317-5556-SP-02	FDA UDI	Class II	Active
OsteoMed	339-5540-SP-02	FDA UDI	Class II	Active
OsteoMed	354-1808-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0406	FDA UDI	Class II	Active
OsteoMed	811-0040	FDA UDI	Class II	Unknown
OsteoMed	220-0720-02	FDA UDI	Class II	Active
OsteoMed	220-0644-109	FDA UDI	Class II	Active
OsteoMed	330-2024-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0643-48	FDA UDI	Class II	Active
OsteoMed	322-2736-SP-02	FDA UDI	Class II	Active
OsteoMed	317-0770-SP-02	FDA UDI	Class II	Active
OsteoMed	354-1820-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0884-01	FDA UDI	Class II	Active
OsteoMed	338-3565-SP-02	FDA UDI	Class II	Active
OsteoMed	811-0015	FDA UDI	Class II	Unknown
OsteoMed	336-0006	FDA UDI	Class II	Active
OsteoMed	210-0304-SP-05	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.