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
HTGClass II

Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

21 CFR 888.3580 / Orthopedic
FDA source (opens on fda.gov)

HTG is the FDA product code for Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented, a class II device type, regulated under 21 CFR 888.3580. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HTG
Device name
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
Regulation
21 CFR 888.3580
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HTG

By decision year
2 clearances under product code HTG with a decision year between 1977 and 1980, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HTG by decision year
YearClearances
19771
19801

Applicants with the most clearances

Product code HTG
Applicants holding the most 510(k) clearances under product code HTG
ApplicantClearances
Depuy, Inc.1
Waldemar Link GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code