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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 22 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	218-0040	FDA UDI	Class II	Active
OsteoMed	220-0641-10	FDA UDI	Class II	Active
OsteoMed	334-2022-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2924-08	FDA UDI	Class II	Active
OsteoMed	320-6009	FDA UDI	Class II	Active
OsteoMed	220-0644-79	FDA UDI	Class II	Active
OsteoMed	375-0001	FDA UDI	Class II	Active
OsteoMed	210-0307	FDA UDI	Class II	Active
OsteoMed	336-5104	FDA UDI	Class II	Active
OsteoMed	336-9203	FDA UDI	Class II	Active
OsteoMed	336-2722-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0116	FDA UDI	Class II	Active
OsteoMed	337-3514	FDA UDI	Class II	Active
OsteoMed	218-0216	FDA UDI	Class II	Active
OsteoMed	210-1044	FDA UDI	Class II	Active
OsteoMed	386-0000	FDA UDI	Class II	Active
OsteoMed	214-0210	FDA UDI	Class II	Active
OsteoMed	220-0701	FDA UDI	Class II	Active
OsteoMed	210-0036-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4551-SP-02	FDA UDI	Class II	Active
OsteoMed	337-2714	FDA UDI	Class II	Active
OsteoMed	319-6091-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0110-SP-02	FDA UDI	Class II	Active
OsteoMed	317-6591	FDA UDI	Class II	Active
OsteoMed	319-5580	FDA UDI	Class II	Active
OsteoMed	319-4530	FDA UDI	Class II	Active
OsteoMed	371-0225	FDA UDI	U	Active
OsteoMed	210-0115	FDA UDI	Class II	Active
OsteoMed	315-4044	FDA UDI	Class II	Active
OsteoMed	318-2410	FDA UDI	Class II	Active
OsteoMed	371-0205	FDA UDI	U	Active
OsteoMed	324-2220	FDA UDI	Class II	Active
OsteoMed	206-2422	FDA UDI	Class II	Active
OsteoMed	354-1834-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0643-50	FDA UDI	Class II	Active
OsteoMed	210-0081	FDA UDI	Class II	Active
OsteoMed	324-2250	FDA UDI	Class II	Active
OsteoMed	216-1200	FDA UDI	Class II	Active
OsteoMed	450-0618	FDA UDI	Class I	Active
OsteoMed	315-2432	FDA UDI	Class II	Active
OsteoMed	317-6586-SP-02	FDA UDI	Class II	Active
OsteoMed	338-4034-SP-02	FDA UDI	Class II	Active
OsteoMed	214-2012	FDA UDI	Class II	Active
OsteoMed	111-1250	FDA UDI	Class II	Active
OsteoMed	330-2428	FDA UDI	Class II	Active
OsteoMed	349-2416	FDA UDI	Class II	Active
OsteoMed	305-2416	FDA UDI	Class II	Active
OsteoMed	302-2008-SP-05	FDA UDI	Class II	Active
OsteoMed	234-2010	FDA UDI	Class II	Active
OsteoMed	319-7086	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.