The following data is part of a premarket notification filed by Implex Corp. with the FDA for Modification To Hedrocel Vertebral Body Replacement, Model Xx-yyy-zzzz.
Device ID | K021025 |
510k Number | K021025 |
Device Name: | MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
Contact | Robert Poggie |
Correspondent | Robert Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-29 |
Decision Date | 2002-05-20 |
Summary: | summary |