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Osteomed Implantes: FDA-registered device maker in Rio Claro Sao Paulo, Brazil, 4 510(k) clearances

Name: Osteomed Implantes FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Osteomed Implantes is registered with the FDA (registration 3023138345) in Rio Claro Sao Paulo, Brazil. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 21, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023138345
Address: Rod Washington Luis km 172 pista sul - cond. ind.conpark, Rio Claro Sao Paulo, Brazil, 13500970
Owner or operator: Osteomed Implantes (10085391)
Roles: Manufacturer
First device listed: June 13, 2022
Registered through: 2026
Brand names listed: Intervertebral body fusion device (Cage's PEEK), Mini-OSTEO Pedicle Fixation System, Pedicle screw spinal system (DPZ), Spinal intervertebral body fixation orthosis Anterior Cervical Plate System.

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 2023	K231443	Mini-OSTEO Pedicle Fixation System	NKB	Substantially Equivalent	Osteomed Indústria E Comércio DE Implantes Ltda	accessdata.fda.gov
February 10, 2016	K151553	Anterior Cervical Plate System	KWQ	Substantially Equivalent	Osteomed Implantes, Ltda	accessdata.fda.gov
June 10, 2015	K143572	Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK	ODP	Substantially Equivalent	Osteomed Implantes, Ltda	accessdata.fda.gov
June 5, 2015	K150294	DPZ Pedicular Fixation System	MNI	Substantially Equivalent	Osteomed Implantes, Ltda	accessdata.fda.gov

Compare with other makers

Updated November 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.