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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 23 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	336-9111	FDA UDI	Class II	Active
OsteoMed	336-3500-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2921	FDA UDI	Class II	Active
OsteoMed	220-0641-39	FDA UDI	Class II	Active
OsteoMed	815-1160-SP	FDA UDI	Class II	Unknown
OsteoMed	316-0050	FDA UDI	Class II	Active
OsteoMed	302-2028	FDA UDI	Class II	Active
OsteoMed	319-7121	FDA UDI	Class II	Active
OsteoMed	338-4080-SP-02	FDA UDI	Class II	Active
OsteoMed	333-1604-SP-02	FDA UDI	Class II	Active
OsteoMed	213-0055-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1386	FDA UDI	Class II	Active
OsteoMed	338-4010	FDA UDI	Class II	Active
OsteoMed	220-0252	FDA UDI	Class II	Active
OsteoMed	114-2015	FDA UDI	Class II	Active
OsteoMed	800-0106-SP	FDA UDI	Class II	Unknown
OsteoMed	323-1514	FDA UDI	Class II	Active
OsteoMed	450-6005-SP	FDA UDI	Class II	Active
OsteoMed	386-1560	FDA UDI	Class II	Active
OsteoMed	450-2215	FDA UDI	Class II	Active
OsteoMed	319-4038-SP-05	FDA UDI	Class II	Active
OsteoMed	212-0068-SP-02	FDA UDI	Class II	Active
OsteoMed	222-0003	FDA UDI	Class II	Active
OsteoMed	333-1609	FDA UDI	Class II	Active
OsteoMed	254-1606-SP	FDA UDI	Class II	Active
OsteoMed	202-2020-SP	FDA UDI	Class II	Active
OsteoMed	336-2710	FDA UDI	Class II	Active
OsteoMed	450-8000-SP	FDA UDI	Class II	Active
OsteoMed	316-1613	FDA UDI	Class II	Active
OsteoMed	342-2716	FDA UDI	Class II	Active
OsteoMed	386-1310	FDA UDI	Class II	Active
OsteoMed	310-2234	FDA UDI	Class II	Active
OsteoMed	320-1060-01	FDA UDI	Class II	Active
OsteoMed	339-4012-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1281-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0462	FDA UDI	Class II	Active
OsteoMed	217-0065	FDA UDI	Class II	Active
OsteoMed	343-2728-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2408-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-36	FDA UDI	Class II	Active
OsteoMed	320-1215-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0035	FDA UDI	Class II	Active
OsteoMed	321-3512-SP-02	FDA UDI	Class II	Active
OsteoMed	358-2410-SP-05	FDA UDI	Class II	Active
OsteoMed	354-1812-SP-05	FDA UDI	Class II	Active
OsteoMed	337-3022-SP-02	FDA UDI	Class II	Active
OsteoMed	337-3010	FDA UDI	Class II	Active
OsteoMed	316-1607	FDA UDI	Class II	Active
OsteoMed	308-3020-SP	FDA UDI	Class II	Active
OsteoMed	317-2424	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.