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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 25 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	220-0119	FDA UDI	Class II	Active
OsteoMed	330-2010	FDA UDI	Class II	Active
OsteoMed	450-2215-SP	FDA UDI	Class II	Active
OsteoMed	216-0000	FDA UDI	Class II	Active
OsteoMed	338-3585-SP-02	FDA UDI	Class II	Active
OsteoMed	331-2026-SP-05	FDA UDI	Class II	Active
OsteoMed	319-2013-SP-05	FDA UDI	Class II	Active
OsteoMed	306-2410-SP	FDA UDI	Class II	Active
OsteoMed	316-0004	FDA UDI	Class II	Active
OsteoMed	3571	FDA UDI	U	Active
OsteoMed	811-0016	FDA UDI	Class II	Unknown
OsteoMed	338-4055-SP-02	FDA UDI	Class II	Active
OsteoMed	336-5107-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-10	FDA UDI	Class II	Active
OsteoMed	815-1150-SP	FDA UDI	Class II	Unknown
OsteoMed	319-7111	FDA UDI	Class II	Active
OsteoMed	218-0176-SP	FDA UDI	Class II	Active
OsteoMed	319-6560	FDA UDI	Class II	Active
OsteoMed	324-1271-SP-05	FDA UDI	Class II	Active
OsteoMed	211-2008-SP-10	FDA UDI	Class II	Active
OsteoMed	209-2011-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0502	FDA UDI	Class II	Active
OsteoMed	319-4026	FDA UDI	Class II	Active
OsteoMed	202-0210	FDA UDI	Class II	Active
OsteoMed	212-0048-SP-02	FDA UDI	Class II	Active
OsteoMed	202-2304-SP-02	FDA UDI	Class II	Active
OsteoMed	213-0182	FDA UDI	Class II	Active
OsteoMed	218-0044	FDA UDI	Class II	Active
OsteoMed	306-2430	FDA UDI	Class II	Active
OsteoMed	209-2316	FDA UDI	Class II	Active
OsteoMed	337-4038	FDA UDI	Class II	Active
OsteoMed	317-2446	FDA UDI	Class II	Active
OsteoMed	218-0225	FDA UDI	Class II	Active
OsteoMed	321-2018-SP-05	FDA UDI	Class II	Active
OsteoMed	212-0069-SP	FDA UDI	Class II	Active
OsteoMed	318-3032	FDA UDI	Class II	Active
OsteoMed	231-2823	FDA UDI	Class II	Active
OsteoMed	359-2418	FDA UDI	Class II	Active
OsteoMed	337-3010-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-14	FDA UDI	Class II	Active
OsteoMed	218-3070-SP	FDA UDI	Class II	Active
OsteoMed	320-2907	FDA UDI	Class II	Active
OsteoMed	330-2024	FDA UDI	Class II	Active
OsteoMed	811-1005	FDA UDI	Class II	Unknown
OsteoMed	333-2052	FDA UDI	Class II	Active
OsteoMed	323-1418	FDA UDI	Class II	Active
OsteoMed	450-0287-90	FDA UDI	Class II	Active
OsteoMed	212-1040-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2770	FDA UDI	Class II	Active
OsteoMed	3575-S	FDA UDI	U	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.