510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922292Substantially Equivalent

Lundeen Subtalar Peg Implant

Sgarlato Laboratories, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922292 is the FDA 510(k) clearance record for LUNDEEN SUBTALAR PEG IMPLANT, a class II device, cleared for Sgarlato Laboratories, Inc. on under FDA product code MJW (Prosthesis, Subtalar, Plug, Polymer). FDA records list 8 510(k) clearances for Sgarlato Laboratories, Inc., from to . As of , FDA records show no recalls naming K922292.

Clearance record

Decision date
Received
(161 days to decision)
Product code
MJW Prosthesis, Subtalar, Plug, Polymer
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Sgarlato Laboratories, Inc. 100 O'Connor Dr., Suite 18, San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code MJW

Trailing 12 months

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

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