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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 13 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	220-0011	FDA UDI	Class II	Active
OsteoMed	338-3522	FDA UDI	Class II	Active
OsteoMed	320-1004	FDA UDI	Class II	Active
OsteoMed	225-2314	FDA UDI	Class II	Active
OsteoMed	213-1662	FDA UDI	Class II	Active
OsteoMed	220-0644-91	FDA UDI	Class II	Active
OsteoMed	213-1634	FDA UDI	Class II	Active
OsteoMed	220-0263	FDA UDI	Class II	Active
OsteoMed	336-5206	FDA UDI	Class II	Active
OsteoMed	220-0883	FDA UDI	Class I	Active
OsteoMed	220-0643-37	FDA UDI	Class II	Active
OsteoMed	220-0566	FDA UDI	Class II	Active
OsteoMed	214-0064	FDA UDI	Class II	Active
OsteoMed	210-0226	FDA UDI	Class II	Active
OsteoMed	322-3510	FDA UDI	Class II	Active
OsteoMed	358-2426-SP-02	FDA UDI	Class II	Active
OsteoMed	320-5016-SP-05	FDA UDI	Class II	Active
OsteoMed	322-4034	FDA UDI	Class II	Active
OsteoMed	330-2018-SP-05	FDA UDI	Class II	Active
OsteoMed	339-5580-SP-02	FDA UDI	Class II	Active
OsteoMed	319-0811-SP-02	FDA UDI	Class II	Active
OsteoMed	321-2738	FDA UDI	Class II	Active
OsteoMed	214-0222	FDA UDI	Class II	Active
OsteoMed	213-0052	FDA UDI	Class II	Active
OsteoMed	220-0644-53	FDA UDI	Class II	Active
OsteoMed	810-2028	FDA UDI	Class II	Unknown
OsteoMed	210-0010-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0643-35	FDA UDI	Class II	Active
OsteoMed	359-2710-SP-02	FDA UDI	Class II	Active
OsteoMed	231-1031T	FDA UDI	Class II	Active
OsteoMed	220-0853	FDA UDI	Class II	Active
OsteoMed	211-2006-SP-10	FDA UDI	Class II	Active
OsteoMed	319-5520	FDA UDI	Class II	Active
OsteoMed	331-2407-SP-05	FDA UDI	Class II	Active
OsteoMed	213-1621	FDA UDI	Class II	Active
OsteoMed	816-0950-SP	FDA UDI	Class II	Unknown
OsteoMed	386-1551	FDA UDI	Class II	Active
OsteoMed	450-0531	FDA UDI	Class II	Active
OsteoMed	321-2740	FDA UDI	Class II	Active
OsteoMed	241-2803	FDA UDI	Class II	Active
OsteoMed	320-4040	FDA UDI	Class II	Active
OsteoMed	330-2011	FDA UDI	Class II	Active
OsteoMed	220-1621	FDA UDI	Class II	Active
OsteoMed	354-1811-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-127	FDA UDI	Class II	Active
OsteoMed	338-4110	FDA UDI	Class II	Active
OsteoMed	451-2015-SP	FDA UDI	Class II	Active
OsteoMed	209-2306	FDA UDI	Class II	Active
OsteoMed	319-6616-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-53	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.