510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231443Substantially Equivalent

Mini-OSTEO Pedicle Fixation System

Osteomed Indústria E Comércio de Implantes Ltda, Rio Claro, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231443 is the FDA 510(k) clearance record for Mini-OSTEO Pedicle Fixation System, a class II device, cleared for Osteomed Indústria E Comércio DE Implantes Ltda on under FDA product code NKB (Thoracolumbosacral Pedicle Screw System). FDA's definition for product code NKB reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". FDA records list one 510(k) clearance for Osteomed Indústria E Comércio DE Implantes Ltda. As of , FDA records show no recalls naming K231443.

Clearance record

Decision date
Received
(187 days to decision)
Product code
NKB Thoracolumbosacral Pedicle Screw System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Osteomed Indústria E Comércio DE Implantes Ltda Washington Luis Rte., 172 Km - Anhanguera'S Garden, Rio Claro, BR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKB

Trailing 12 months
29 clearances under product code NKB in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code NKB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20263
March 20260
April 20265
May 20264
June 20262
July 20264
August 20260
September 20265
October 20260