FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

HAND INNOVATIONS, INC.

The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Fragment Plate System, Screws, Pins And K-wires.

Pre-market Notification Details

• Device ID: K041081
• 510k Number: K041081
• Device Name: FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: HAND INNOVATIONS, INC. 8905 SW 87TH AVE. Miami, FL 33176 -2227
• Contact: Al Weisenborn
• Correspondent: Al Weisenborn; HAND INNOVATIONS, INC. 8905 SW 87TH AVE. Miami, FL 33176 -2227
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-26
• Decision Date: 2004-07-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868012501	K041081	000
00887868012495	K041081	000
00887868012488	K041081	000
00887868012471	K041081	000