510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952543Substantially Equivalent

Graftologer Pgh & Acl Reconstruction Instrument Set

Neoligaments, Ltd., Leeds, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952543 is the FDA 510(k) clearance record for GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET, a class I device, cleared for Neoligaments, Ltd. on under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment). FDA records list 7 510(k) clearances for Neoligaments, Ltd., from to . As of , FDA records show no recalls naming K952543.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Neoligaments, Ltd. 28-30 Blenheim Ter., Leeds, GB
510(k) summary
Statement
Third party review
No

Clearances, product code HWE

Trailing 12 months

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

FDA records show no clearances under product code HWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HWE, 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