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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 9 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	321-2710	FDA UDI	Class II	Active
OsteoMed	359-2424-SP-02	FDA UDI	Class II	Active
OsteoMed	330-2020-SP-05	FDA UDI	Class II	Active
OsteoMed	322-4055-SP-02	FDA UDI	Class II	Active
OsteoMed	349-2422-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-99	FDA UDI	Class II	Active
OsteoMed	336-0002	FDA UDI	Class II	Active
OsteoMed	320-0422	FDA UDI	Class II	Active
OsteoMed	220-0003	FDA UDI	Class II	Active
OsteoMed	395-2200	FDA UDI	Class II	Active
OsteoMed	320-0010	FDA UDI	Class II	Active
OsteoMed	317-0781	FDA UDI	Class II	Active
OsteoMed	319-2026-SP-05	FDA UDI	Class II	Active
OsteoMed	321-4018	FDA UDI	Class II	Active
OsteoMed	337-2730	FDA UDI	Class II	Active
OsteoMed	220-0007	FDA UDI	Class II	Active
OsteoMed	354-1830-SP-05	FDA UDI	Class II	Active
OsteoMed	330-2022-SP-05	FDA UDI	Class II	Active
OsteoMed	232-2418	FDA UDI	Class II	Active
OsteoMed	336-0004	FDA UDI	Class II	Active
OsteoMed	220-0640-162	FDA UDI	Class II	Active
OsteoMed	214-0207-SP-02	FDA UDI	Class II	Active
OsteoMed	218-1603	FDA UDI	Class II	Active
OsteoMed	220-0644-28	FDA UDI	Class II	Active
OsteoMed	324-1280-SP-05	FDA UDI	Class II	Active
OsteoMed	218-0213-SP-05	FDA UDI	Class II	Active
OsteoMed	214-0382	FDA UDI	Class II	Active
OsteoMed	390-8500	FDA UDI	Class II	Active
OsteoMed	450-1614-SP	FDA UDI	Class II	Active
OsteoMed	316-1400	FDA UDI	Class II	Active
OsteoMed	331-2010	FDA UDI	Class II	Active
OsteoMed	359-2718-SP-02	FDA UDI	Class II	Active
OsteoMed	214-0218	FDA UDI	Class II	Active
OsteoMed	220-0640-163	FDA UDI	Class II	Active
OsteoMed	338-4032-SP-02	FDA UDI	Class II	Active
OsteoMed	218-0202	FDA UDI	Class II	Active
OsteoMed	320-0409	FDA UDI	Class I	Active
OsteoMed	333-2408	FDA UDI	Class II	Active
OsteoMed	354-1819-SP-05	FDA UDI	Class II	Active
OsteoMed	395-2027-SP-02	FDA UDI	Class II	Active
OsteoMed	210-0412	FDA UDI	Class II	Active
OsteoMed	202-1206	FDA UDI	Class II	Active
OsteoMed	324-2224	FDA UDI	Class II	Active
OsteoMed	214-0099	FDA UDI	Class II	Active
OsteoMed	317-5581-SP-02	FDA UDI	Class II	Active
OsteoMed	319-6071-SP	FDA UDI	Class II	Active
OsteoMed	214-0215T	FDA UDI	Class II	Active
OsteoMed	214-0062	FDA UDI	Class II	Active
OsteoMed	218-0203-SP-05	FDA UDI	Class II	Active
OsteoMed	317-3011-SP-05	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.