SYMMETRIC TOTAL KNEE AGUMENTS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

SIGNAL MEDICAL CORP.

The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Symmetric Total Knee Aguments.

Pre-market Notification Details

• Device ID: K100370
• 510k Number: K100370
• Device Name: SYMMETRIC TOTAL KNEE AGUMENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SIGNAL MEDICAL CORP. 1000 DES PERES ROAD SUITE 140 St. Louis, MO 63131
• Contact: Brian Katerberg
• Correspondent: Brian Katerberg; SIGNAL MEDICAL CORP. 1000 DES PERES ROAD SUITE 140 St. Louis, MO 63131
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-12
• Decision Date: 2011-03-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G611WZC26550	K100370	000
G611220811161000	K100370	000
G611220811161500	K100370	000
G611220811162000	K100370	000
G611220811181000	K100370	000
G611220811181500	K100370	000
G611220811182000	K100370	000
G611220811201000	K100370	000
G611220811201500	K100370	000
G611220811202000	K100370	000
G611220811221000	K100370	000
G611220811221500	K100370	000
G611220811222000	K100370	000
G611220811241000	K100370	000
G611220811241500	K100370	000
G611220811242000	K100370	000
G611220811261000	K100370	000
G611220811262000	K100370	000
G611220811142000	K100370	000
G611220811141500	K100370	000
G611220811141000	K100370	000
G611WZC26560	K100370	000
G611WZC26570	K100370	000
G611WZC26580	K100370	000
G611WZC26590	K100370	000
G611WZC26600	K100370	000
G611WZC26610	K100370	000
G611WZC26620	K100370	000
G611WZC26630	K100370	000
G611WZC26640	K100370	000
G611WZC26650	K100370	000
G611WZC26660	K100370	000
G611220811101000	K100370	000
G611220811101500	K100370	000
G611220811102000	K100370	000
G611220811121000	K100370	000
G611220811121500	K100370	000
G611220811122000	K100370	000
G611220910450	K100370	000
G611220811261500	K100370	000
B046220811101500	K100370	000
B046220811182000	K100370	000
B046220811201000	K100370	000
B046220811202000	K100370	000
B046220811221500	K100370	000
B046220811222000	K100370	000
B046220811241500	K100370	000
B046WZC26550	K100370	000
B046WZC26560	K100370	000
B046WZC26570	K100370	000
B046WZC26580	K100370	000
B046WZC26590	K100370	000
B046WZC26600	K100370	000
B046WZC26610	K100370	000
B046WZC26620	K100370	000
B046WZC26630	K100370	000
B046WZC26640	K100370	000
B046WZC26650	K100370	000
B046220811181000	K100370	000
B046220811162000	K100370	000
B046220811161500	K100370	000
B046220811221000	K100370	000
B046220811241000	K100370	000
B046220811242000	K100370	000
B046220811261000	K100370	000
B046220811262000	K100370	000
B046220811101000	K100370	000
B046220811102000	K100370	000
B046220811122000	K100370	000
B046220811121000	K100370	000
B046220811261500	K100370	000
B046220811121500	K100370	000
B046220811181500	K100370	000
B046220811201500	K100370	000
B046220811141000	K100370	000
B046220811141500	K100370	000
B046220811142000	K100370	000
B046220811161000	K100370	000
B046WZC26660	K100370	000