510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161426Substantially Equivalent

NeoSpan Compression Staple Impant w/instruments

In2bones USA, LLC, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161426 is the FDA 510(k) clearance record for NeoSpan Compression Staple Impant w/instruments, a class II device, cleared for In2bones USA, LLC on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 27 510(k) clearances for In2bones USA, LLC, from to . As of , FDA records show 2 recalls naming K161426.

Clearance record

Decision date
Received
(154 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
In2bones USA, LLC 6060 Poplar Ave., Memphis TN
510(k) summary
Summary PDF
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