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: K132244
• 510k Number: K132244
• 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: 2013-07-18
• Decision Date: 2014-03-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815612020564	K132244	000
00815612020373	K132244	000
00815612020366	K132244	000
00815612020359	K132244	000
00815612020342	K132244	000
00815612020335	K132244	000
00815612020328	K132244	000
00815612020311	K132244	000
00815612020304	K132244	000
00815612020298	K132244	000
00815612020281	K132244	000
00815612020274	K132244	000
00815612020267	K132244	000
00815612020250	K132244	000
00815612020243	K132244	000
00815612020236	K132244	000
00815612020380	K132244	000
00815612020397	K132244	000
00815612020403	K132244	000
00815612020557	K132244	000
00815612020540	K132244	000
00815612020533	K132244	000
00815612020526	K132244	000
00815612020519	K132244	000
00815612020502	K132244	000
00815612020496	K132244	000
00815612020489	K132244	000
00815612020472	K132244	000
00815612020465	K132244	000
00815612020458	K132244	000
00815612020441	K132244	000
00815612020434	K132244	000
00815612020427	K132244	000
00815612020410	K132244	000
00815612020229	K132244	000