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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 4 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	317-2018-SP-05	FDA UDI	Class II	Active
OsteoMed	336-1006	FDA UDI	Class II	Active
OsteoMed	317-2428	FDA UDI	Class II	Active
OsteoMed	386-1318	FDA UDI	Class II	Active
OsteoMed	316-0102	FDA UDI	Class II	Active
OsteoMed	360-2200	FDA UDI	Class II	Active
OsteoMed	205-1206	FDA UDI	Class II	Active
OsteoMed	318-2034	FDA UDI	Class II	Active
OsteoMed	319-2440-SP-05	FDA UDI	Class II	Active
OsteoMed	231-1001T	FDA UDI	Class II	Active
OsteoMed	308-1614	FDA UDI	Class II	Active
OsteoMed	208-1604-CD	FDA UDI	Class II	Active
OsteoMed	338-3526-SP-02	FDA UDI	Class II	Active
OsteoMed	213-0003	FDA UDI	Class II	Active
OsteoMed	220-0003-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0641-12	FDA UDI	Class II	Active
OsteoMed	220-0640-57	FDA UDI	Class II	Active
OsteoMed	319-0796	FDA UDI	Class II	Active
OsteoMed	317-0805-SP-02	FDA UDI	Class II	Active
OsteoMed	319-0790	FDA UDI	Class II	Active
OsteoMed	339-4546	FDA UDI	Class II	Active
OsteoMed	220-0643-49	FDA UDI	Class II	Active
OsteoMed	220-0644-89	FDA UDI	Class II	Active
OsteoMed	231-2021	FDA UDI	Class II	Active
OsteoMed	338-4030	FDA UDI	Class II	Active
OsteoMed	322-4010-SP-02	FDA UDI	Class II	Active
OsteoMed	231-1042T	FDA UDI	Class II	Active
OsteoMed	210-3007-SP	FDA UDI	Class II	Active
OsteoMed	218-2015-SP	FDA UDI	Class II	Active
OsteoMed	306-2430-SP	FDA UDI	Class II	Active
OsteoMed	225-2312	FDA UDI	Class II	Active
OsteoMed	319-7071	FDA UDI	Class II	Active
OsteoMed	206-2406-SP	FDA UDI	Class II	Active
OsteoMed	218-0032-SP	FDA UDI	Class II	Active
OsteoMed	218-3080-SP	FDA UDI	Class II	Active
OsteoMed	209-1906	FDA UDI	Class II	Active
OsteoMed	338-4055	FDA UDI	Class II	Active
OsteoMed	455-7702	FDA UDI	Class II	Active
OsteoMed	214-0056	FDA UDI	Class II	Active
OsteoMed	210-0105	FDA UDI	Class II	Active
OsteoMed	317-4528	FDA UDI	Class II	Active
OsteoMed	220-0643-52	FDA UDI	Class II	Active
OsteoMed	331-1612-SP-05	FDA UDI	Class II	Active
OsteoMed	317-4044-SP-05	FDA UDI	Class II	Active
OsteoMed	322-2736	FDA UDI	Class II	Active
OsteoMed	455-3701	FDA UDI	Class II	Active
OsteoMed	359-2732	FDA UDI	Class II	Active
OsteoMed	220-0641-29	FDA UDI	Class II	Active
OsteoMed	813-0955-SP	FDA UDI	Class II	Unknown
OsteoMed	330-2409	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.