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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 12 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	111-0950	FDA UDI	Class II	Active
OsteoMed	800-0118-SP	FDA UDI	Class II	Unknown
OsteoMed	214-0265T	FDA UDI	Class II	Active
OsteoMed	214-0262T	FDA UDI	Class II	Active
OsteoMed	320-2627-SP-02	FDA UDI	Class II	Active
OsteoMed	315-2426	FDA UDI	Class II	Active
OsteoMed	214-0057T	FDA UDI	Class II	Active
OsteoMed	220-0572	FDA UDI	Class II	Active
OsteoMed	324-1190	FDA UDI	Class II	Active
OsteoMed	317-4570-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0560-SP-02	FDA UDI	Class II	Active
OsteoMed	234-2320	FDA UDI	Class II	Active
OsteoMed	811-0008	FDA UDI	Class II	Unknown
OsteoMed	337-3575-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2412-SP-05	FDA UDI	Class II	Active
OsteoMed	354-1815-SP-02	FDA UDI	Class II	Active
OsteoMed	337-4040-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1292-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-94	FDA UDI	Class II	Active
OsteoMed	355-0601	FDA UDI	Class II	Active
OsteoMed	336-2760-SP-02	FDA UDI	Class II	Active
OsteoMed	333-1208	FDA UDI	Class II	Active
OsteoMed	220-0076	FDA UDI	Class II	Active
OsteoMed	812-1730-SP	FDA UDI	Class II	Unknown
OsteoMed	317-4040	FDA UDI	Class II	Active
OsteoMed	220-0640-61	FDA UDI	Class II	Active
OsteoMed	319-0791	FDA UDI	Class II	Active
OsteoMed	204-1204-SP-10	FDA UDI	Class II	Active
OsteoMed	800-0135-10	FDA UDI	Class II	Unknown
OsteoMed	220-0255	FDA UDI	Class II	Active
OsteoMed	317-5549-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2728	FDA UDI	Class II	Active
OsteoMed	319-4550-SP-02	FDA UDI	Class II	Active
OsteoMed	316-1604-SP-02	FDA UDI	Class II	Active
OsteoMed	319-5547-SP-02	FDA UDI	Class II	Active
OsteoMed	317-6610	FDA UDI	Class II	Active
OsteoMed	210-0206-SP-02	FDA UDI	Class II	Active
OsteoMed	216-1001	FDA UDI	Class II	Active
OsteoMed	319-0801	FDA UDI	Class II	Active
OsteoMed	337-2710	FDA UDI	Class II	Active
OsteoMed	319-4549	FDA UDI	Class II	Active
OsteoMed	317-6605	FDA UDI	Class II	Active
OsteoMed	355-0305-SP-02	FDA UDI	Class II	Active
OsteoMed	210-1032	FDA UDI	Class II	Active
OsteoMed	320-0007	FDA UDI	Class II	Active
OsteoMed	216-1614	FDA UDI	Class II	Active
OsteoMed	319-2042	FDA UDI	Class II	Active
OsteoMed	334-2020	FDA UDI	Class II	Active
OsteoMed	210-1061	FDA UDI	Class II	Active
OsteoMed	220-0641-02	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.