The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Vertebral Body Replacement, Model Xx-yyy-zzzz.
| Device ID | K010378 |
| 510k Number | K010378 |
| Device Name: | 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 | John Schalago |
| Correspondent | John Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-08 |
| Decision Date | 2002-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024314092 | K010378 | 000 |
| 00889024314085 | K010378 | 000 |
| 00889024314078 | K010378 | 000 |
| 00889024314061 | K010378 | 000 |
| 00889024314054 | K010378 | 000 |
| 00889024314047 | K010378 | 000 |
| 00889024314030 | K010378 | 000 |