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: K022778
• 510k Number: K022778
• 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 Treharne
• Correspondent: Richard 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: 2002-08-22
• Decision Date: 2002-09-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885074291307	K022778	000
00721902276538	K022778	000
00721902276620	K022778	000
00721902276637	K022778	000
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00681490909884	K022778	000
00681490909914	K022778	000
00681490909921	K022778	000
00613994391209	K022778	000
00721902276521	K022778	000
00721902276446	K022778	000
00885074291314	K022778	000
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00885074291338	K022778	000
00885074291345	K022778	000
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00885074291369	K022778	000
00885074291376	K022778	000
00721902276293	K022778	000
00721902276309	K022778	000
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00613994391407	K022778	000
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00613994391278	K022778	000
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00613994391292	K022778	000
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00613994391315	K022778	000
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00613994391339	K022778	000
00613994391469	K022778	000