PLW · Class II · 21 CFR 888.3350

FDA Product Code PLW: Acetabular Cup Orientation System

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.

Leading manufacturers include Materialise NV.

Total

Cleared

216d

Avg days

2015

Since

FDA 510(k) Cleared Acetabular Cup Orientation System Devices (Product Code PLW)

1 devices

1–1 of 1

Cleared Oct 27, 2015

Acetabular Cup Orientation System

K150780

Materialise NV

Orthopedic · 216d

About Product Code PLW - Regulatory Context

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Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Oct 27, 2015

Product Code Info

Code	PLW
Device class	Class II
CFR	21 CFR 888.3350
Panel	Orthopedic

Verify on FDA.gov

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