510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800363Substantially Equivalent

Parke-Davis Total Knee Prosthesis

Warner-Lambert Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800363 is the FDA 510(k) clearance record for PARKE-DAVIS TOTAL KNEE PROSTHESIS, a class I device, cleared for Warner-Lambert Co. on under FDA product code KTZ (Caliper). FDA records list 50 510(k) clearances for Warner-Lambert Co., from to . As of , FDA records show no recalls naming K800363.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KTZ Caliper
Regulation
21 CFR 888.4150
Device class
Class I
Review panel
Orthopedic
Applicant
Warner-Lambert Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTZ

Trailing 12 months

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

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