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
NTGClass III

Prosthesis, Ankle, Uncemented, Non-Constrained

Unknown
FDA source (opens on fda.gov)

NTG is the FDA product code for Prosthesis, Ankle, Uncemented, Non-Constrained, a class III device type. FDA's definition for this code reads: "An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses...". As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
NTG
Device name
Prosthesis, Ankle, Uncemented, Non-Constrained
FDA definition
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order