The following data is part of a premarket notification filed by Implex Corp. with the FDA for Trabecular Metal Vertebral Body Replacement.
| Device ID | K051978 |
| 510k Number | K051978 |
| Device Name: | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT |
| 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 | 2005-07-21 |
| Decision Date | 2005-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024314696 | K051978 | 000 |
| 00889024314689 | K051978 | 000 |
| 00889024314672 | K051978 | 000 |
| 00889024314665 | K051978 | 000 |
| 00889024314658 | K051978 | 000 |