SYMPHONY™ OCT System

Posterior Cervical Screw System

Medos International Sarl

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Symphony™ Oct System.

Pre-market Notification Details

• Device ID: K203319
• 510k Number: K203319
• Device Name: SYMPHONY™ OCT System
• Classification: Posterior Cervical Screw System
• Applicant: Medos International Sarl Chemin Blanc 38 Lelocle, CH 2400
• Contact: Eric Zhu
• Correspondent: Eric Zhu; DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-12
• Decision Date: 2021-02-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034524535	K203319	000
10705034519272	K203319	000
10705034519289	K203319	000
10705034519296	K203319	000
10705034519302	K203319	000
10705034519319	K203319	000
10705034519326	K203319	000
10705034519333	K203319	000
10705034521701	K203319	000
10705034521718	K203319	000
10705034523279	K203319	000
10705034523286	K203319	000
10705034524504	K203319	000
10705034524511	K203319	000
10705034524528	K203319	000
10705034519265	K203319	000