Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023138345

FEI Number

3023138345

Entity Name

OSTEOMED IMPLANTES

City/State/Country

Rio Claro Sao Paulo, BR

Establishment Address

Rod Washington Luis km 172, pista sul - cond. ind.conpark, Rio Claro Sao Paulo 13500970, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osteomed Implantes (Owner Number: 10085391)

Owner / Operator Contact Address

Rod Washington Luis km 172, pista sul - cond. ind.conpark, Rio Claro, BR-SP 13500970, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231443

PMA Number

N/A

All Registered Proprietary Names

Intervertebral body fusion device (Cage's PEEK) Mini-OSTEO Pedicle Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-06-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-06-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-12-19

Official Correspondent

Fernando Argenton Neto

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

Osteomed Implantes

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
2134947	GAUTHIER BIOMEDICAL, INC.	Grafton, WI, US
1526534	Sterigenics US, LLC	Lewis Center, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023138345. Last updated year: 2026. Please use registration number 3023138345 when referencing this establishment in official correspondence.