SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS

Appliance, Fixation, Spinal Interlaminal

SOFAMOR DANEK MFG., INC.

The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Sentry(tm) Anterior/posterior Spinal Systems.

Pre-market Notification Details

• Device ID: K936294
• 510k Number: K936294
• Device Name: SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131
• Contact: Richard W Treharne
• Correspondent: Richard W Treharne; SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131
• Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-10
• Decision Date: 1995-12-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00681490499354	K936294	000
00673978042404	K936294	000
00673978042411	K936294	000
00673978042510	K936294	000
00673978042527	K936294	000
00673978042534	K936294	000
00673978947907	K936294	000
00673978947914	K936294	000
00673978947921	K936294	000
00673978947945	K936294	000
00673978947952	K936294	000
00673978947969	K936294	000
00673978947976	K936294	000
00673978042398	K936294	000