SIERRA

Appliance, Fixation, Spinal Interlaminal

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Sierra.

Pre-market Notification Details

• Device ID: K072729
• 510k Number: K072729
• Device Name: SIERRA
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Contact: Ethel Bernal
• Correspondent: Ethel Bernal; SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-26
• Decision Date: 2008-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10889981059163	K072729	000
10889910059158	K072729	000
10889910059141	K072729	000
10889910059134	K072729	000
10889910059127	K072729	000
10889910059110	K072729	000
10889910059103	K072729	000
10889910059097	K072729	000
10889910059080	K072729	000
10889910059073	K072729	000
10889910059066	K072729	000
10889910059059	K072729	000
10889910059042	K072729	000
10889910059165	K072729	000
10889981059033	K072729	000
10889981059156	K072729	000
10889981059149	K072729	000
10889981059132	K072729	000
10889981059125	K072729	000
10889981059118	K072729	000
10889981059101	K072729	000
10889981059095	K072729	000
10889981059088	K072729	000
10889981059071	K072729	000
10889981059064	K072729	000
10889981059057	K072729	000
10889981059040	K072729	000
10889910059035	K072729	000