UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

PISHARODI SURGICALS, INC.

The following data is part of a premarket notification filed by Pisharodi Surgicals, Inc. with the FDA for Universal Multiaxis (unimax) Pedicle Screw System.

Pre-market Notification Details

• Device ID: K014302
• 510k Number: K014302
• Device Name: UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: PISHARODI SURGICALS, INC. 942 WILDROSE LN. Brownsville, TX 78520
• Contact: Madhaven Pisharodi
• Correspondent: Madhaven Pisharodi; PISHARODI SURGICALS, INC. 942 WILDROSE LN. Brownsville, TX 78520
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-31
• Decision Date: 2002-03-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852647007009	K014302	000
00852647007177	K014302	000
00852647007184	K014302	000
00852647007191	K014302	000
00852647007207	K014302	000
00852647007214	K014302	000
00852647007221	K014302	000
00852647007238	K014302	000
00852647007245	K014302	000
00852647007252	K014302	000
00852647007269	K014302	000
00852647007276	K014302	000
00852647007283	K014302	000
00852647007290	K014302	000
00852647007160	K014302	000
00852647007153	K014302	000
00852647007146	K014302	000
00852647007016	K014302	000
00852647007023	K014302	000
00852647007030	K014302	000
00852647007047	K014302	000
00852647007054	K014302	000
00852647007061	K014302	000
00852647007078	K014302	000
00852647007085	K014302	000
00852647007092	K014302	000
00852647007108	K014302	000
00852647007115	K014302	000
00852647007122	K014302	000
00852647007139	K014302	000
00852647007306	K014302	000
00852647007313	K014302	000
00852647007320	K014302	000
00852647007498	K014302	000
00852647007504	K014302	000
00852647007511	K014302	000
00852647007528	K014302	000
00852647007535	K014302	000
00852647007542	K014302	000
00852647007559	K014302	000
00852647007566	K014302	000
00852647007573	K014302	000
00852647007580	K014302	000
00852647007597	K014302	000
00852647007955	K014302	000
00852647007962	K014302	000
00852647007481	K014302	000
00852647007474	K014302	000
00852647007467	K014302	000
00852647007337	K014302	000
00852647007344	K014302	000
00852647007351	K014302	000
00852647007368	K014302	000
00852647007375	K014302	000
00852647007382	K014302	000
00852647007399	K014302	000
00852647007405	K014302	000
00852647007412	K014302	000
00852647007429	K014302	000
00852647007436	K014302	000
00852647007443	K014302	000
00852647007450	K014302	000
00852647007979	K014302	000