Altus Spine Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Altus Partners, LLC

The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Pedicle Screw System.

Pre-market Notification Details

• Device ID: K211027
• 510k Number: K211027
• Device Name: Altus Spine Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380
• Contact: Mark Melton
• Correspondent: Rand Baker; Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-06
• Decision Date: 2022-09-16

NIH GUDID Devices

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