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

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

21 CFR 888.3370 / Orthopedic
FDA source (opens on fda.gov)

KWB is the FDA product code for Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal, a class III device type, regulated under 21 CFR 888.3370. FDA's definition for this code reads: "Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
KWB
Device name
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
FDA definition
Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Regulation
21 CFR 888.3370
Device class
Class III
Review panel
Orthopedic
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code