510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980928Substantially Equivalent

Synthes Spine Universal Spinal Hook, Rod, Pedicle/sacral Screw Fixation System

Synthes GmbH, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980928 is the FDA 510(k) clearance record for SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM, a class II device, cleared for Synthes Spine on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 62 510(k) clearances for SYNTHES GMBH, from to . As of , FDA records show no recalls naming K980928.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes Spine P.O. Box 0548, Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260