MODIFICATION TO TSRH SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Tsrh Spinal System.

Pre-market Notification Details

• Device ID: K000991
• 510k Number: K000991
• Device Name: MODIFICATION TO TSRH SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard W Treharne
• Correspondent: Richard W Treharne; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-28
• Decision Date: 2000-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00721902021893	K000991	000
00673978139692	K000991	000
00673978139708	K000991	000
00673978139715	K000991	000
00673978139722	K000991	000
00673978139739	K000991	000
00673978139746	K000991	000
00673978139753	K000991	000
00673978139760	K000991	000
00673978144030	K000991	000
00673978144047	K000991	000
00673978137209	K000991	000
00673978137193	K000991	000
00673978137186	K000991	000
00721902021909	K000991	000
00721902021930	K000991	000
00721902021978	K000991	000
00721902022005	K000991	000
00721902022012	K000991	000
00721902022029	K000991	000
00721902022036	K000991	000
00721902022043	K000991	000
00673978130385	K000991	000
00673978137179	K000991	000
00673978144054	K000991	000
00673978144061	K000991	000
00673978152660	K000991	000
00673978154695	K000991	000
00673978154732	K000991	000
00673978154749	K000991	000
00673978154756	K000991	000
00673978154763	K000991	000
00673978154770	K000991	000
00673978154787	K000991	000
00673978154794	K000991	000
00673978974514	K000991	000
00673978152639	K000991	000
00673978152622	K000991	000
00673978152615	K000991	000
00673978144832	K000991	000
00673978144849	K000991	000
00673978144856	K000991	000
00673978144917	K000991	000
00673978144924	K000991	000
00673978144931	K000991	000
00673978144948	K000991	000
00673978152554	K000991	000
00673978152561	K000991	000
00673978152578	K000991	000
00673978997704	K000991	000