ORTHOLOC™ SPS Shoulder Plating System

Plate, Fixation, Bone

Tornier Inc.

The following data is part of a premarket notification filed by Tornier Inc. with the FDA for Ortholoc™ Sps Shoulder Plating System.

Pre-market Notification Details

• Device ID: K191711
• 510k Number: K191711
• Device Name: ORTHOLOC™ SPS Shoulder Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55437
• Contact: Renee Stoffel
• Correspondent: Renee Stoffel; Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55437
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: KTT
• Subsequent Product Code: KTW
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-26
• Decision Date: 2019-07-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846832075041	K191711	000
00846832074877	K191711	000
00846832074884	K191711	000
00846832074891	K191711	000
00846832074907	K191711	000
00846832074914	K191711	000
00846832074921	K191711	000
00846832074938	K191711	000
00846832074945	K191711	000
00846832074952	K191711	000
00846832074969	K191711	000
00846832074976	K191711	000
00846832074983	K191711	000
00846832074990	K191711	000
00846832075003	K191711	000
00846832075010	K191711	000
00846832075027	K191711	000
00846832075034	K191711	000
00846832074860	K191711	000