N-FORCE FIXATION SYSTEM

Screw, Fixation, Bone

INNOVISION, INC.

The following data is part of a premarket notification filed by Innovision, Inc. with the FDA for N-force Fixation System.

Pre-market Notification Details

• Device ID: K102528
• 510k Number: K102528
• Device Name: N-FORCE FIXATION SYSTEM
• Classification: Screw, Fixation, Bone
• Applicant: INNOVISION, INC. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Contact: Michelle Mcdonough
• Correspondent: Michelle Mcdonough; INNOVISION, INC. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-03
• Decision Date: 2011-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815612020212	K102528	000
00815612020090	K102528	000
00815612020083	K102528	000
00815612020076	K102528	000
00815612020069	K102528	000
00815612020052	K102528	000
00815612020045	K102528	000
00815612020038	K102528	000
00815612020021	K102528	000
00815612020014	K102528	000
00815612020106	K102528	000
00815612020113	K102528	000
00815612020205	K102528	000
00815612020199	K102528	000
00815612020182	K102528	000
00815612020175	K102528	000
00815612020168	K102528	000
00815612020151	K102528	000
00815612020144	K102528	000
00815612020137	K102528	000
00815612020120	K102528	000
00815612020007	K102528	000