510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897141Substantially Equivalent for Some Indications

Slot Staples and Adaptor for Zielke Spinal Fixatio

Stuart, Greensburg PA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K897141 is the FDA 510(k) clearance record for SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO, a class II device, cleared for Stuart on under FDA product code JDN (Implant, Fixation Device, Spinal). FDA records list 5 510(k) clearances for Stuart, from to . As of , FDA records show no recalls naming K897141.

Clearance record

Decision date
Received
(176 days to decision)
Product code
JDN Implant, Fixation Device, Spinal
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Stuart One Stuart Plz., Greensburg PA
Third party review
No

Clearances, product code JDN

Trailing 12 months

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

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