The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Vertebral Body Replacement, Model 06-172-00xx1.
| Device ID | K031823 |
| 510k Number | K031823 |
| Device Name: | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi 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 | 2003-06-13 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024314191 | K031823 | 000 |
| 00889024314016 | K031823 | 000 |
| 00889024314009 | K031823 | 000 |
| 00889024313996 | K031823 | 000 |
| 00889024313989 | K031823 | 000 |
| 00889024313972 | K031823 | 000 |
| 00889024313965 | K031823 | 000 |
| 00889024313958 | K031823 | 000 |
| 00889024313941 | K031823 | 000 |
| 00889024314023 | K031823 | 000 |
| 00889024314108 | K031823 | 000 |
| 00889024314184 | K031823 | 000 |
| 00889024314177 | K031823 | 000 |
| 00889024314160 | K031823 | 000 |
| 00889024314153 | K031823 | 000 |
| 00889024314146 | K031823 | 000 |
| 00889024314139 | K031823 | 000 |
| 00889024314122 | K031823 | 000 |
| 00889024314115 | K031823 | 000 |
| 00889024313934 | K031823 | 000 |