Versafitcup Cc Trio

510(k) Number

K103352 ↗

FDA product code

LZO

FDA applicant

Medacta International

Device class

Class II

Regulation

21 CFR Part 888.3353

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

• Avenir Complete® 574777240 by Zimmer, Inc.
• U-Motion II™ 1306-2062 by UNITED ORTHOPEDIC CORP.
• Trinity No Hole Shells 321.04.056 by CORIN LTD
• Wagner Cone Prosthesis® 75.11.00-09 by Zimmer, Inc.
• G7® 010002487 by Biomet Orthopedics, Inc.
• MiniHip Stem 580.9063 by CORIN LTD
• MP Reconstruction Prosthesis 172-985/26 by WALDEMAR LINK GmbH & Co. KG
• OSTEONICS ANTEVERTED NECK HIP STEM by Osteonics Corp.
• TREGOR DUAL MOBILITY ACETABULAR SYSTEM by Aston Medical
• Klassic HD® Hip System by TOTAL JOINT ORTHOPEDICS, INC.

• Fixed tibial tray cementless S.2R

  Class III

  CE/MDD

• X-Acta Rasp Offset 37.5mm CDH Size 0

  Class I

  CE/MDD

• Flex E-cross trial insert S6L - 13 mm

  Class IIa

  CE/MDD

• Trial Neck Anteverted LAT #2-3 Right

  Class IIa

  CE/MDD

See all devices from Medacta International SA →