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

Acetabular Cup Orientation System

21 CFR 888.3350 / Orthopedic
FDA source (opens on fda.gov)

PLW is the FDA product code for Acetabular Cup Orientation System, a class II device type, regulated under 21 CFR 888.3350. FDA's definition for this code reads: "The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PLW
Device name
Acetabular Cup Orientation System
FDA definition
The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PLW

By decision year
1 clearance under product code PLW with a decision year between 2015 and 2015, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLW by decision year
YearClearances
20151

Applicants with the most clearances

Product code PLW
Applicants holding the most 510(k) clearances under product code PLW
ApplicantClearances
Materialise N.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code