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
K153302Substantially Equivalent

coflex-IF

Paradigm Spine GmbH, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153302 is the FDA 510(k) clearance record for coflex-IF, a class II device, cleared for Paradigm Spine, LLC on under FDA product code PEK (Spinous Process Plate). FDA's definition for product code PEK reads: "A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental...". FDA records list 16 510(k) clearances for Paradigm Spine, LLC, from to . As of , FDA records show no recalls naming K153302.

Clearance record

Decision date
Received
(300 days to decision)
Product code
PEK Spinous Process Plate
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Paradigm Spine, LLC 505 Park Ave. 14th Floor, New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEK

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