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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 2 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	210-0010-SP	FDA UDI	Class II	Active
OsteoMed	339-6555-SP-02	FDA UDI	Class II	Active
OsteoMed	320-1516	FDA UDI	Class II	Active
OsteoMed	336-3564	FDA UDI	Class II	Active
OsteoMed	354-1818-SP-05	FDA UDI	Class II	Active
OsteoMed	395-2000-SP-05	FDA UDI	Class II	Active
OsteoMed	358-2411-SP-02	FDA UDI	Class II	Active
OsteoMed	315-2410	FDA UDI	Class II	Active
OsteoMed	322-3545	FDA UDI	Class II	Active
OsteoMed	355-0300-SP-02	FDA UDI	Class II	Active
OsteoMed	213-0205	FDA UDI	Class II	Active
OsteoMed	330-1614	FDA UDI	Class II	Active
OsteoMed	322-2008	FDA UDI	Class II	Active
OsteoMed	220-0607	FDA UDI	Class II	Active
OsteoMed	322-4038	FDA UDI	Class II	Active
OsteoMed	317-5538	FDA UDI	Class II	Active
OsteoMed	360-2810	FDA UDI	Class II	Active
OsteoMed	211-1604-REV-C	FDA UDI	Class II	Active
OsteoMed	450-0648	FDA UDI	Class II	Active
OsteoMed	210-1042	FDA UDI	Class II	Active
OsteoMed	359-2438-SP-05	FDA UDI	Class II	Active
OsteoMed	324-2250-SP-02	FDA UDI	Class II	Active
OsteoMed	337-3532-SP-02	FDA UDI	Class II	Active
OsteoMed	324-1110-SP-02	FDA UDI	Class II	Active
OsteoMed	317-2424-SP-05	FDA UDI	Class II	Active
OsteoMed	207-2414	FDA UDI	Class II	Active
OsteoMed	318-4028	FDA UDI	Class II	Active
OsteoMed	210-0208	FDA UDI	Class II	Active
OsteoMed	319-6070	FDA UDI	Class II	Active
OsteoMed	317-6545	FDA UDI	Class II	Active
OsteoMed	358-2711-SP-05	FDA UDI	Class II	Active
OsteoMed	214-0114	FDA UDI	Class II	Active
OsteoMed	320-0072	FDA UDI	Class II	Active
OsteoMed	358-2440	FDA UDI	Class II	Active
OsteoMed	334-2434	FDA UDI	Class II	Active
OsteoMed	813-1009	FDA UDI	Class II	Unknown
OsteoMed	305-2410	FDA UDI	Class II	Active
OsteoMed	213-0057-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0711	FDA UDI	Class II	Active
OsteoMed	218-0205	FDA UDI	Class II	Active
OsteoMed	331-2020	FDA UDI	Class II	Active
OsteoMed	319-6070-SP	FDA UDI	Class II	Active
OsteoMed	320-5118-SP-05	FDA UDI	Class II	Active
OsteoMed	324-1284-SP-02	FDA UDI	Class II	Active
OsteoMed	232-2706	FDA UDI	Class II	Active
OsteoMed	336-2121	FDA UDI	Class II	Active
OsteoMed	810-2024	FDA UDI	Class II	Unknown
OsteoMed	319-4532-SP-02	FDA UDI	Class II	Active
OsteoMed	317-6571	FDA UDI	Class II	Active
OsteoMed	358-2409-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.