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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 5 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	322-3532	FDA UDI	Class II	Active
OsteoMed	218-2001-SP	FDA UDI	Class II	Active
OsteoMed	220-0643-83	FDA UDI	Class II	Active
OsteoMed	450-2226-SP	FDA UDI	Class II	Active
OsteoMed	210-0320	FDA UDI	Class II	Active
OsteoMed	220-0324	FDA UDI	Class I	Active
OsteoMed	217-0080	FDA UDI	Class II	Active
OsteoMed	330-2018	FDA UDI	Class II	Active
OsteoMed	450-0610	FDA UDI	Class I	Active
OsteoMed	395-2124	FDA UDI	Class II	Active
OsteoMed	331-1614	FDA UDI	Class II	Active
OsteoMed	220-0578	FDA UDI	Class II	Active
OsteoMed	811-0022	FDA UDI	Class II	Unknown
OsteoMed	210-0040	FDA UDI	Class II	Active
OsteoMed	308-3036-SP-05	FDA UDI	Class II	Active
OsteoMed	339-4040-SP-02	FDA UDI	Class II	Active
OsteoMed	213-0040	FDA UDI	Class II	Active
OsteoMed	202-1608	FDA UDI	Class II	Active
OsteoMed	318-2024	FDA UDI	Class II	Active
OsteoMed	213-0154	FDA UDI	Class II	Active
OsteoMed	302-2032-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-73	FDA UDI	Class II	Active
OsteoMed	231-2814	FDA UDI	Class II	Active
OsteoMed	320-2400	FDA UDI	Class II	Active
OsteoMed	204-1208-SP	FDA UDI	Class II	Active
OsteoMed	339-5526-SP-02	FDA UDI	Class II	Active
OsteoMed	359-2426	FDA UDI	Class II	Active
OsteoMed	214-0053T	FDA UDI	Class II	Active
OsteoMed	225-2416	FDA UDI	Class II	Active
OsteoMed	110-0025	FDA UDI	Class II	Active
OsteoMed	316-0545	FDA UDI	Class I	Active
OsteoMed	338-4012-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2925-11	FDA UDI	Class II	Active
OsteoMed	332-1210	FDA UDI	Class II	Active
OsteoMed	814-0755-SP	FDA UDI	Class II	Unknown
OsteoMed	319-7120	FDA UDI	Class II	Active
OsteoMed	320-1215	FDA UDI	Class II	Active
OsteoMed	358-2410	FDA UDI	Class II	Active
OsteoMed	312-2203	FDA UDI	Class II	Active
OsteoMed	114-1221	FDA UDI	Class II	Active
OsteoMed	359-2428	FDA UDI	Class II	Active
OsteoMed	336-2221-SP-02	FDA UDI	Class II	Active
OsteoMed	321-4032-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-91	FDA UDI	Class II	Active
OsteoMed	213-1609	FDA UDI	Class II	Active
OsteoMed	810-1012	FDA UDI	Class II	Unknown
OsteoMed	450-3050	FDA UDI	Class II	Active
OsteoMed	814-0930-SP	FDA UDI	Class II	Unknown
OsteoMed	231-1521	FDA UDI	Class II	Active
OsteoMed	331-1207	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.