510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012081Substantially Equivalent

Dynamic Compression Shape Memory Alloy (Sma) Staple System

Medtronic Sofamor Danek, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012081 is the FDA 510(k) clearance record for DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM, a class II device, cleared for Medtronic Sofamor Danek, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 253 510(k) clearances for Medtronic Sofamor Danek, Inc., from to . As of , FDA records show no recalls naming K012081.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Medtronic Sofamor Danek, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code JDR

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