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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 16 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	317-5526	FDA UDI	Class II	Active
OsteoMed	321-3522	FDA UDI	Class II	Active
OsteoMed	317-0776-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0245-SP	FDA UDI	Class II	Active
OsteoMed	811-0107	FDA UDI	Class II	Unknown
OsteoMed	220-0643-23	FDA UDI	Class II	Active
OsteoMed	336-9105	FDA UDI	Class II	Active
OsteoMed	319-6576	FDA UDI	Class II	Active
OsteoMed	231-1513T	FDA UDI	Class II	Active
OsteoMed	308-3034-SP-05	FDA UDI	Class II	Active
OsteoMed	345-4560	FDA UDI	Class II	Active
OsteoMed	342-2724-SP-02	FDA UDI	Class II	Active
OsteoMed	338-3550-SP-02	FDA UDI	Class II	Active
OsteoMed	337-3512-SP-02	FDA UDI	Class II	Active
OsteoMed	321-4038-SP-02	FDA UDI	Class II	Active
OsteoMed	210-1022	FDA UDI	Class II	Active
OsteoMed	336-6103	FDA UDI	Class II	Active
OsteoMed	815-1135-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0644-12	FDA UDI	Class II	Active
OsteoMed	336-6108	FDA UDI	Class II	Active
OsteoMed	336-5111-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0610	FDA UDI	Class II	Active
OsteoMed	450-6004	FDA UDI	Class II	Active
OsteoMed	336-9301	FDA UDI	Class II	Active
OsteoMed	220-0202	FDA UDI	Class II	Active
OsteoMed	354-1828-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-63	FDA UDI	Class II	Active
OsteoMed	111-1661	FDA UDI	Class II	Active
OsteoMed	337-4048	FDA UDI	Class II	Active
OsteoMed	218-0076-SP	FDA UDI	Class II	Active
OsteoMed	359-2430	FDA UDI	Class II	Active
OsteoMed	331-2432	FDA UDI	Class II	Active
OsteoMed	214-0084	FDA UDI	Class II	Active
OsteoMed	338-3570	FDA UDI	Class II	Active
OsteoMed	220-0620-02	FDA UDI	Class II	Active
OsteoMed	319-2432	FDA UDI	Class II	Active
OsteoMed	341-1013	FDA UDI	Class II	Active
OsteoMed	317-0760	FDA UDI	Class II	Active
OsteoMed	345-5545	FDA UDI	Class II	Active
OsteoMed	319-5551-SP-02	FDA UDI	Class II	Active
OsteoMed	450-1634	FDA UDI	Class I	Active
OsteoMed	320-1030	FDA UDI	Class II	Active
OsteoMed	816-0930-SP	FDA UDI	Class II	Unknown
OsteoMed	334-2428-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0326	FDA UDI	Class II	Active
OsteoMed	400-3721-SP	FDA UDI	Class II	Active
OsteoMed	319-4555	FDA UDI	Class II	Active
OsteoMed	319-6546	FDA UDI	Class II	Active
OsteoMed	320-1224	FDA UDI	Class II	Active
OsteoMed	319-2422	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.