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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 18 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	319-6590-SP-02	FDA UDI	Class II	Active
OsteoMed	811-0045	FDA UDI	Class II	Unknown
OsteoMed	214-2046	FDA UDI	Class II	Active
OsteoMed	337-4012-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4530-SP-05	FDA UDI	Class II	Active
OsteoMed	332-1213	FDA UDI	Class II	Active
OsteoMed	359-2716-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0140	FDA UDI	Class II	Active
OsteoMed	333-1620	FDA UDI	Class II	Active
OsteoMed	317-6615	FDA UDI	Class II	Active
OsteoMed	451-2055-SP	FDA UDI	Class II	Active
OsteoMed	322-4032	FDA UDI	Class II	Active
OsteoMed	302-2018	FDA UDI	Class II	Active
OsteoMed	319-6591	FDA UDI	Class II	Active
OsteoMed	319-5543	FDA UDI	Class II	Active
OsteoMed	214-0402	FDA UDI	Class II	Active
OsteoMed	213-0081	FDA UDI	Class II	Active
OsteoMed	317-0771	FDA UDI	Class II	Active
OsteoMed	339-6560-SP-02	FDA UDI	Class II	Active
OsteoMed	202-0212	FDA UDI	Class II	Active
OsteoMed	320-6308	FDA UDI	Class II	Active
OsteoMed	358-2732-SP-02	FDA UDI	Class II	Active
OsteoMed	319-7115-SP-02	FDA UDI	Class II	Active
OsteoMed	339-6540-SP-02	FDA UDI	Class II	Active
OsteoMed	323-1719	FDA UDI	Class II	Active
OsteoMed	202-2010	FDA UDI	Class II	Active
OsteoMed	210-0503	FDA UDI	Class II	Active
OsteoMed	320-1065	FDA UDI	Class II	Active
OsteoMed	319-6545	FDA UDI	Class II	Active
OsteoMed	319-6091-SP	FDA UDI	Class II	Active
OsteoMed	210-1210	FDA UDI	Class II	Active
OsteoMed	339-5575	FDA UDI	Class II	Active
OsteoMed	317-5524-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4520-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-116	FDA UDI	Class II	Active
OsteoMed	218-0211	FDA UDI	Class II	Active
OsteoMed	210-1039	FDA UDI	Class II	Active
OsteoMed	316-1124	FDA UDI	Class II	Active
OsteoMed	349-2413	FDA UDI	Class II	Active
OsteoMed	336-5209-SP-02	FDA UDI	Class II	Active
OsteoMed	305-2412	FDA UDI	Class II	Active
OsteoMed	812-1735-SP	FDA UDI	Class II	Unknown
OsteoMed	338-2728-SP-05	FDA UDI	Class II	Active
OsteoMed	206-2413	FDA UDI	Class II	Active
OsteoMed	800-0308	FDA UDI	Class II	Unknown
OsteoMed	336-6209-SP-02	FDA UDI	Class II	Active
OsteoMed	320-2335	FDA UDI	Class II	Active
OsteoMed	217-0082	FDA UDI	Class II	Active
OsteoMed	330-2028	FDA UDI	Class II	Active
OsteoMed	220-0511	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.