510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K150552Substantially Equivalent

ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS

Globus Medical, Inc., Audubon PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150552 is the FDA 510(k) clearance record for ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS, a class II device, cleared for Globus Medical, Inc. 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 217 510(k) clearances for Globus Medical, Inc., from to . As of , FDA records show one recall naming K150552.

Clearance record

Decision date
Received
(92 days to decision)
Product code
NKG Posterior Cervical Screw System
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Applicant
Globus Medical, Inc. 2560 General Armistead Ave., Audubon PA
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