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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 20 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	336-2734	FDA UDI	Class II	Active
OsteoMed	320-0418	FDA UDI	Class II	Active
OsteoMed	331-1206	FDA UDI	Class II	Active
OsteoMed	345-6560-SP-02	FDA UDI	Class II	Active
OsteoMed	317-4550	FDA UDI	Class II	Active
OsteoMed	450-0350	FDA UDI	Class II	Active
OsteoMed	339-4524	FDA UDI	Class II	Active
OsteoMed	358-2738	FDA UDI	Class II	Active
OsteoMed	320-2803	FDA UDI	Class II	Active
OsteoMed	816-1013	FDA UDI	Class II	Unknown
OsteoMed	217-1215	FDA UDI	Class II	Active
OsteoMed	316-0533	FDA UDI	Class I	Active
OsteoMed	319-6066	FDA UDI	Class II	Active
OsteoMed	220-0641-66	FDA UDI	Class II	Active
OsteoMed	316-0002	FDA UDI	Class II	Active
OsteoMed	358-2726-SP-05	FDA UDI	Class II	Active
OsteoMed	342-2732-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0043	FDA UDI	Class II	Active
OsteoMed	358-2424-SP-05	FDA UDI	Class II	Active
OsteoMed	450-1027-SP	FDA UDI	Class II	Active
OsteoMed	202-0208	FDA UDI	Class II	Active
OsteoMed	811-0036	FDA UDI	Class II	Unknown
OsteoMed	322-3526	FDA UDI	Class II	Active
OsteoMed	316-0014	FDA UDI	Class II	Active
OsteoMed	210-0220	FDA UDI	Class II	Active
OsteoMed	811-0215	FDA UDI	Class II	Unknown
OsteoMed	320-1012	FDA UDI	Class II	Active
OsteoMed	317-6565-SP-02	FDA UDI	Class II	Active
OsteoMed	316-0537	FDA UDI	Class I	Active
OsteoMed	390-8502	FDA UDI	Class II	Active
OsteoMed	319-7070-SP-02	FDA UDI	Class II	Active
OsteoMed	315-3020	FDA UDI	Class II	Active
OsteoMed	337-4060-SP-02	FDA UDI	Class II	Active
OsteoMed	324-2222-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0643-55	FDA UDI	Class II	Active
OsteoMed	220-0265	FDA UDI	Class II	Active
OsteoMed	202-1210	FDA UDI	Class II	Active
OsteoMed	218-0061-SP	FDA UDI	Class II	Active
OsteoMed	220-0528	FDA UDI	Class II	Active
OsteoMed	319-5570-SP-02	FDA UDI	Class II	Active
OsteoMed	322-3555	FDA UDI	Class II	Active
OsteoMed	216-1202	FDA UDI	Class II	Active
OsteoMed	330-2034-SP-02	FDA UDI	Class II	Active
OsteoMed	450-0647	FDA UDI	Class II	Active
OsteoMed	337-3030	FDA UDI	Class II	Active
OsteoMed	321-0004-SP-02	FDA UDI	Class II	Active
OsteoMed	386-1321	FDA UDI	Class II	Active
OsteoMed	320-1106	FDA UDI	Class II	Active
OsteoMed	319-5541-SP-02	FDA UDI	Class II	Active
OsteoMed	816-1130-SP	FDA UDI	Class II	Unknown

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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.