The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Vertebral Body Replacement, Models 06-112-00xx2 And 06-132-10xx2.
| Device ID | K021967 |
| 510k Number | K021967 |
| Device Name: | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert A Poggie |
| Correspondent | Robert A 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 | 2002-06-17 |
| Decision Date | 2002-07-17 |
| Summary: | summary |