510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896471Substantially Equivalent

Tenstaple Orthopedic Stapling System

Tenstaple, Inc., Melvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896471 is the FDA 510(k) clearance record for TENSTAPLE ORTHOPEDIC STAPLING SYSTEM, a class II device, cleared for Tenstaple, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Tenstaple, Inc. As of , FDA records show no recalls naming K896471.

Clearance record

Decision date
Received
(253 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Tenstaple, Inc. 1178 Wisteria Dr., Melvern PA
Third party review
No

Clearances, product code JDR

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