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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 8 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	319-6540-SP-02	FDA UDI	Class II	Active
OsteoMed	210-3003-SP	FDA UDI	Class II	Active
OsteoMed	316-0120	FDA UDI	Class II	Active
OsteoMed	217-1904	FDA UDI	Class II	Active
OsteoMed	319-6081	FDA UDI	Class II	Active
OsteoMed	322-4026-SP-02	FDA UDI	Class II	Active
OsteoMed	336-5208-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-10	FDA UDI	Class II	Active
OsteoMed	3550K-S	FDA UDI	U	Active
OsteoMed	336-3541-SP-02	FDA UDI	Class II	Active
OsteoMed	337-4010-SP-02	FDA UDI	Class II	Active
OsteoMed	319-6560-SP-02	FDA UDI	Class II	Active
OsteoMed	330-2034	FDA UDI	Class II	Active
OsteoMed	318-4036	FDA UDI	Class II	Active
OsteoMed	315-2444	FDA UDI	Class II	Active
OsteoMed	349-2423-SP-02	FDA UDI	Class II	Active
OsteoMed	358-2409-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2408-SP-05	FDA UDI	Class II	Active
OsteoMed	349-2428	FDA UDI	Class II	Active
OsteoMed	339-6605-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0022-SP-05	FDA UDI	Class II	Active
OsteoMed	816-1355-SP	FDA UDI	Class II	Unknown
OsteoMed	333-2002	FDA UDI	Class II	Active
OsteoMed	218-0091	FDA UDI	Class II	Active
OsteoMed	816-1015	FDA UDI	Class II	Unknown
OsteoMed	212-0030-SP	FDA UDI	Class II	Active
OsteoMed	315-2030	FDA UDI	Class II	Active
OsteoMed	359-2436	FDA UDI	Class II	Active
OsteoMed	220-0640-46	FDA UDI	Class II	Active
OsteoMed	218-3155-SP	FDA UDI	Class II	Active
OsteoMed	214-2033	FDA UDI	Class II	Active
OsteoMed	317-5536	FDA UDI	Class II	Active
OsteoMed	317-2022-SP-05	FDA UDI	Class II	Active
OsteoMed	358-2415-SP-02	FDA UDI	Class II	Active
OsteoMed	320-5000-SP-05	FDA UDI	Class II	Active
OsteoMed	339-4030-SP-02	FDA UDI	Class II	Active
OsteoMed	331-1211-SP-05	FDA UDI	Class II	Active
OsteoMed	810-0020	FDA UDI	Class II	Unknown
OsteoMed	308-3016-SP	FDA UDI	Class II	Active
OsteoMed	214-0231	FDA UDI	Class II	Active
OsteoMed	210-1046	FDA UDI	Class II	Active
OsteoMed	359-2732-SP-02	FDA UDI	Class II	Active
OsteoMed	214-0217	FDA UDI	Class II	Active
OsteoMed	322-2726	FDA UDI	Class II	Active
OsteoMed	331-1214	FDA UDI	Class II	Active
OsteoMed	450-1610-SP	FDA UDI	Class II	Active
OsteoMed	450-0214	FDA UDI	Class II	Active
OsteoMed	812-1015	FDA UDI	Class II	Unknown
OsteoMed	319-7065-SP	FDA UDI	Class II	Active
OsteoMed	319-6060-SP	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.