510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800800Substantially Equivalent

Patellar Component for Lubinus Patellar

Waldemar Link GmbH & Co. KG, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800800 is the FDA 510(k) clearance record for PATELLAR COMPONENT FOR LUBINUS PATELLAR, a class II device, cleared for Waldemar Link GmbH & Co. KG on under FDA product code HTG (Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented). FDA records list 43 510(k) clearances for Waldemar Link GmbH & Co. KG, from to . As of , FDA records show no recalls naming K800800.

Clearance record

Decision date
Received
(11 days to decision)
Product code
HTG Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
Regulation
21 CFR 888.3580
Device class
Class II
Review panel
Orthopedic
Applicant
Waldemar Link GmbH & Co. KG 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HTG

Trailing 12 months

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

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