510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K885146Substantially Equivalent

Cl Universal Hip Device

Lima Intl. Corp., E Providence RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885146 is the FDA 510(k) clearance record for CL UNIVERSAL HIP DEVICE, a class II device, cleared for Lima Intl. Corp. on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list 8 510(k) clearances for Lima Intl. Corp., from to . As of , FDA records show no recalls naming K885146.

Clearance record

Decision date
Received
(130 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Lima Intl. Corp. 392 Wampanoag Trl., E Providence RI
Third party review
No

Clearances, product code KWI

Trailing 12 months
1 clearance under product code KWI in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260