Is this your brand? Sign in to claim ownership.

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 15 of 161

Device	Model / Reference	Registries	Class	Status
OsteoMed	214-0092-SP-02	FDA UDI	Class II	Active
OsteoMed	302-2013	FDA UDI	Class II	Active
OsteoMed	336-2754	FDA UDI	Class II	Active
OsteoMed	336-9102	FDA UDI	Class II	Active
OsteoMed	214-0221T	FDA UDI	Class II	Active
OsteoMed	349-2428-SP-02	FDA UDI	Class II	Active
OsteoMed	220-0644-37	FDA UDI	Class II	Active
OsteoMed	810-1001	FDA UDI	Class II	Unknown
OsteoMed	375-0004	FDA UDI	Class II	Active
OsteoMed	213-0000	FDA UDI	Class II	Active
OsteoMed	210-0321	FDA UDI	Class II	Active
OsteoMed	339-4068-SP	FDA UDI	Class II	Active
OsteoMed	385-0019	FDA UDI	Class II	Active
OsteoMed	334-2426	FDA UDI	Class II	Active
OsteoMed	220-0704	FDA UDI	Class II	Active
OsteoMed	386-1017	FDA UDI	Class II	Active
OsteoMed	319-2450	FDA UDI	Class II	Active
OsteoMed	214-0211T	FDA UDI	Class II	Active
OsteoMed	220-0421	FDA UDI	Class I	Active
OsteoMed	336-0012-SP-02	FDA UDI	Class II	Active
OsteoMed	317-2028	FDA UDI	Class II	Active
OsteoMed	306-2422-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0640-149	FDA UDI	Class II	Active
OsteoMed	333-1612	FDA UDI	Class II	Active
OsteoMed	324-2208-SP-02	FDA UDI	Class II	Active
OsteoMed	330-2032-SP-02	FDA UDI	Class II	Active
OsteoMed	337-3595	FDA UDI	Class II	Active
OsteoMed	214-2050	FDA UDI	Class II	Active
OsteoMed	450-0005-00	FDA UDI	Class II	Active
OsteoMed	204-1503	FDA UDI	Class II	Active
OsteoMed	214-0202-SP-02	FDA UDI	Class II	Active
OsteoMed	349-2430-SP-02	FDA UDI	Class II	Active
OsteoMed	322-2745-SP-02	FDA UDI	Class II	Active
OsteoMed	231-2051	FDA UDI	Class II	Active
OsteoMed	321-2016-SP-05	FDA UDI	Class II	Active
OsteoMed	220-0832	FDA UDI	Class II	Active
OsteoMed	319-4016	FDA UDI	Class II	Active
OsteoMed	319-4032	FDA UDI	Class II	Active
OsteoMed	337-3595-SP-02	FDA UDI	Class II	Active
OsteoMed	319-5542	FDA UDI	Class II	Active
OsteoMed	220-0641-62	FDA UDI	Class II	Active
OsteoMed	317-2444	FDA UDI	Class II	Active
OsteoMed	332-1211	FDA UDI	Class II	Active
OsteoMed	812-0730-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0261	FDA UDI	Class II	Active
OsteoMed	306-2428-SP-05	FDA UDI	Class II	Active
OsteoMed	210-3005-SP	FDA UDI	Class II	Active
OsteoMed	814-1360-SP	FDA UDI	Class II	Unknown
OsteoMed	220-0641-53	FDA UDI	Class II	Active
OsteoMed	220-0613-05	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.