The following data is part of a premarket notification filed by Implex Corp. with the FDA for Trabecular Metal Vertebral Body Replacement, Model 06-165-011x1 And 06-166-051x1.
| Device ID | K051196 |
| 510k Number | K051196 |
| Device Name: | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | IMPLEX CORP. 80 COMMERCE DRIVE Allendale, NJ 07401 -1600 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi IMPLEX CORP. 80 COMMERCE DRIVE 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 | 2005-05-10 |
| Decision Date | 2005-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024314641 | K051196 | 000 |
| 00889024314535 | K051196 | 000 |
| 00889024314528 | K051196 | 000 |
| 00889024314511 | K051196 | 000 |
| 00889024314504 | K051196 | 000 |
| 00889024314498 | K051196 | 000 |
| 00889024314481 | K051196 | 000 |
| 00889024314474 | K051196 | 000 |
| 00889024314467 | K051196 | 000 |
| 00889024314542 | K051196 | 000 |
| 00889024314559 | K051196 | 000 |
| 00889024314634 | K051196 | 000 |
| 00889024314627 | K051196 | 000 |
| 00889024314610 | K051196 | 000 |
| 00889024314603 | K051196 | 000 |
| 00889024314597 | K051196 | 000 |
| 00889024314580 | K051196 | 000 |
| 00889024314573 | K051196 | 000 |
| 00889024314566 | K051196 | 000 |
| 00889024314450 | K051196 | 000 |