HEX BUTTON

Washer, Bolt Nut

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Hex Button.

Pre-market Notification Details

• Device ID: K992617
• 510k Number: K992617
• Device Name: HEX BUTTON
• Classification: Washer, Bolt Nut
• Applicant: PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Contact: Burns Severson
• Correspondent: Burns Severson; PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Product Code: HTN
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-04
• Decision Date: 1999-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846468064037	K992617	000
H67904221003S0	K992617	000
H67904221004S0	K992617	000
H67902221002S0	K992617	000
H67902221003S0	K992617	000
H67902221004S0	K992617	000
H6792988050	K992617	000
H6794988040	K992617	000
H6794988050	K992617	000
00846468063979	K992617	000
00846468063986	K992617	000
00846468063993	K992617	000
00846468064006	K992617	000
00846468064020	K992617	000
H67904221002S0	K992617	000