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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 10 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	210-0006-SP-05	FDA UDI	Class II	Active
OsteoMed	234-2324	FDA UDI	Class II	Active
OsteoMed	319-6076-SP-02	FDA UDI	Class II	Active
OsteoMed	317-3013	FDA UDI	Class II	Active
OsteoMed	220-0620-04	FDA UDI	Class II	Active
OsteoMed	372-0075	FDA UDI	U	Active
OsteoMed	320-1616	FDA UDI	Class II	Active
OsteoMed	320-4046	FDA UDI	Class I	Active
OsteoMed	220-0319	FDA UDI	Class II	Active
OsteoMed	317-2016	FDA UDI	Class II	Active
OsteoMed	337-3570-SP-02	FDA UDI	Class II	Active
OsteoMed	319-7045	FDA UDI	Class II	Active
OsteoMed	338-4042-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0214-SP-05	FDA UDI	Class II	Active
OsteoMed	320-2712	FDA UDI	Class II	Active
OsteoMed	218-3040-SP	FDA UDI	Class II	Active
OsteoMed	316-0116-SP-02	FDA UDI	Class II	Active
OsteoMed	209-1914	FDA UDI	Class II	Active
OsteoMed	220-0640-01	FDA UDI	Class II	Active
OsteoMed	213-0065	FDA UDI	Class II	Active
OsteoMed	338-2722	FDA UDI	Class II	Active
OsteoMed	319-7080-SP	FDA UDI	Class II	Active
OsteoMed	811-0028	FDA UDI	Class II	Unknown
OsteoMed	359-2410-SP-02	FDA UDI	Class II	Active
OsteoMed	358-2720	FDA UDI	Class II	Active
OsteoMed	220-0613-12	FDA UDI	Class II	Active
OsteoMed	375-0003	FDA UDI	Class II	Active
OsteoMed	317-4544-SP-05	FDA UDI	Class II	Active
OsteoMed	214-0082-SP	FDA UDI	Class II	Active
OsteoMed	371-0235	FDA UDI	U	Active
OsteoMed	316-1740	FDA UDI	Class II	Active
OsteoMed	110-0030	FDA UDI	Class II	Active
OsteoMed	315-2420	FDA UDI	Class II	Active
OsteoMed	322-3545-SP-02	FDA UDI	Class II	Active
OsteoMed	336-5109-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0640-104	FDA UDI	Class II	Active
OsteoMed	337-4055-SP-02	FDA UDI	Class II	Active
OsteoMed	354-1819-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1252-SP-02	FDA UDI	Class II	Active
OsteoMed	815-1335-SP	FDA UDI	Class II	Unknown
OsteoMed	455-4701	FDA UDI	Class II	Active
OsteoMed	220-0640-65	FDA UDI	Class II	Active
OsteoMed	220-0644-36	FDA UDI	Class II	Active
OsteoMed	317-2012-SP-05	FDA UDI	Class II	Active
OsteoMed	320-1120	FDA UDI	Class II	Active
OsteoMed	302-2007	FDA UDI	Class II	Active
OsteoMed	220-0619-04	FDA UDI	Class II	Active
OsteoMed	220-0641-04	FDA UDI	Class II	Active
OsteoMed	214-2041	FDA UDI	Class II	Active
OsteoMed	316-0554	FDA UDI	Class I	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.