510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971900Substantially Equivalent

Lateral Flare Internal Collar (Lfic)

Pro-Lfic, LLC, Greenwich CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971900 is the FDA 510(k) clearance record for LATERAL FLARE INTERNAL COLLAR (LFIC), a class II device, cleared for Pro-Lfic, LLC on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list one 510(k) clearance for Pro-Lfic, LLC. As of , FDA records show no recalls naming K971900.

Clearance record

Decision date
Received
(209 days to decision)
Product code
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Pro-Lfic, LLC 500 W. Putnam Ave., 3rd Flr., Greenwich CT
510(k) summary
Statement
Third party review
No

Clearances, product code LWJ

Trailing 12 months

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

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