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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 27 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	213-0062-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0801-05	FDA UDI	Class II	Active
OsteoMed	316-0032	FDA UDI	Class II	Active
OsteoMed	816-1735-SP	FDA UDI	Class II	Unknown
OsteoMed	800-0219	FDA UDI	Class II	Unknown
OsteoMed	308-1611	FDA UDI	Class II	Active
OsteoMed	316-0323	FDA UDI	Class II	Active
OsteoMed	358-2420-SP-02	FDA UDI	Class II	Active
OsteoMed	321-2712	FDA UDI	Class II	Active
OsteoMed	204-1202	FDA UDI	Class II	Active
OsteoMed	319-6075-SP	FDA UDI	Class II	Active
OsteoMed	334-2032	FDA UDI	Class II	Active
OsteoMed	336-5102-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-90	FDA UDI	Class II	Active
OsteoMed	220-0117	FDA UDI	Class II	Active
OsteoMed	330-2008	FDA UDI	Class II	Active
OsteoMed	324-1090	FDA UDI	Class II	Active
OsteoMed	317-6560-SP-02	FDA UDI	Class II	Active
OsteoMed	318-3012	FDA UDI	Class II	Active
OsteoMed	319-7046-SP-02	FDA UDI	Class II	Active
OsteoMed	319-2413-SP-05	FDA UDI	Class II	Active
OsteoMed	214-2404	FDA UDI	Class II	Active
OsteoMed	319-2406	FDA UDI	Class II	Active
OsteoMed	451-2052-SP	FDA UDI	Class II	Active
OsteoMed	400-7777-SP	FDA UDI	Class II	Active
OsteoMed	317-2018	FDA UDI	Class II	Active
OsteoMed	220-0641-52	FDA UDI	Class II	Active
OsteoMed	338-4095	FDA UDI	Class II	Active
OsteoMed	314-2114	FDA UDI	Class II	Active
OsteoMed	319-6070-SP-02	FDA UDI	Class II	Active
OsteoMed	800-1206	FDA UDI	U	Unknown
OsteoMed	214-0052T	FDA UDI	Class II	Active
OsteoMed	220-0640-159	FDA UDI	Class II	Active
OsteoMed	450-0390	FDA UDI	Class II	Active
OsteoMed	320-2700	FDA UDI	Class II	Active
OsteoMed	210-0040-SP-02	FDA UDI	Class II	Active
OsteoMed	319-2011	FDA UDI	Class II	Active
OsteoMed	333-2012	FDA UDI	Class II	Active
OsteoMed	450-1626	FDA UDI	Class II	Active
OsteoMed	319-4018-SP-05	FDA UDI	Class II	Active
OsteoMed	210-0102-SP-02	FDA UDI	Class II	Active
OsteoMed	337-2799	FDA UDI	Class II	Active
OsteoMed	218-0207	FDA UDI	Class II	Active
OsteoMed	333-2413	FDA UDI	Class II	Active
OsteoMed	213-0009	FDA UDI	Class II	Active
OsteoMed	220-0318	FDA UDI	Class II	Active
OsteoMed	321-4020	FDA UDI	Class II	Active
OsteoMed	320-2940	FDA UDI	Class II	Active
OsteoMed	302-2034-SP-05	FDA UDI	Class II	Active
OsteoMed	330-1612-SP-05	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.