510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953764Substantially Equivalent

Lmt Bone Anchor

Li Medical Technologies, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953764 is the FDA 510(k) clearance record for LMT BONE ANCHOR, a class II device, cleared for Li Medical Technologies, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 17 510(k) clearances for Li Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K953764.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Li Medical Technologies, Inc. 4 Armstrong Rd., Shelton CT
510(k) summary
Statement
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