Platform® Acetabular System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Total Joint Orthopedics, Inc.

The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Platform® Acetabular System.

Pre-market Notification Details

• Device ID: K220483
• 510k Number: K220483
• Device Name: Platform® Acetabular System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Contact: Chris Weaber
• Correspondent: Holly Rhodes; Mcra LLC. 803 7th Street NW Washington, DC 20001
• Product Code: LZO
• Subsequent Product Code: LPH
• Subsequent Product Code: MBL
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-18
• Decision Date: 2022-09-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814703017476	K220483	000
00814703017278	K220483	000
00814703017261	K220483	000
00814703017254	K220483	000
00814703017247	K220483	000
00814703017230	K220483	000
00814703017223	K220483	000
00814703017216	K220483	000
00814703017209	K220483	000
00814703017193	K220483	000
00814703017186	K220483	000
00814703017179	K220483	000
00814703017162	K220483	000
00814703017155	K220483	000
00814703017148	K220483	000
00814703017131	K220483	000
00814703017124	K220483	000
00814703017285	K220483	000
00814703017292	K220483	000
00814703017308	K220483	000
00814703017469	K220483	000
00814703017452	K220483	000
00814703017445	K220483	000
00814703017438	K220483	000
00814703017421	K220483	000
00814703017414	K220483	000
00814703017407	K220483	000
00814703017391	K220483	000
00814703017384	K220483	000
00814703017377	K220483	000
00814703017360	K220483	000
00814703017353	K220483	000
00814703017346	K220483	000
00814703017339	K220483	000
00814703017322	K220483	000
00814703017315	K220483	000
00814703017117	K220483	000