510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K254045Substantially Equivalent

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

CarboFix Orthopedics Inc., Herzeliya, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254045 is the FDA 510(k) clearance record for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System, a class II device, cleared for CarboFix Orthopedics , Ltd. on under FDA product code NKG (Posterior Cervical Screw System). FDA's definition for product code NKG reads: "Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4)...". FDA records list 32 510(k) clearances for CarboFix Orthopedics , Ltd., from to . As of , FDA records show no recalls naming K254045.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NKG Posterior Cervical Screw System
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Applicant
CarboFix Orthopedics , Ltd. 11 Ha'Hoshlim St., Herzeliya, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKG

Trailing 12 months
5 clearances under product code NKG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NKG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260