The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Cannulated Screw System.
Device ID | K003496 |
510k Number | K003496 |
Device Name: | CANNULATED SCREW SYSTEM |
Classification | Washer, Bolt Nut |
Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
Contact | Amy H Mommaerts |
Correspondent | Amy H Mommaerts 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 | 2000-11-13 |
Decision Date | 2001-02-08 |
Summary: | summary |