The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Spl Crimp System.
Device ID | K002110 |
510k Number | K002110 |
Device Name: | SPL CRIMP SYSTEM |
Classification | Cerclage, Fixation |
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 | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-12 |
Decision Date | 2000-10-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98149199201S0 | K002110 | 000 |
H98149199101S0 | K002110 | 000 |
H98129199201S0 | K002110 | 000 |
H98129199101S0 | K002110 | 000 |