Acetabular Plates

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002941 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What is the Acetabular Plates device used for?

  The Acetabular Plates are an orthopedic device used in medical procedures, but the specific indication is not provided in the device data.

• How is the Acetabular Plates device supplied?

  The Acetabular Plates are supplied by Encore Orthopedics, Inc. and stored and distributed according to the manufacturer's instructions.

• What is the regulatory status of the Acetabular Plates device?

  The Acetabular Plates have been cleared through the Traditional 510(k) pathway with FDA 510K clearance, indicated by the k number K002941.