The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for The Zimmer Tmt Trabecular Metal Vertebral Body Replacement System.
Device ID | K052950 |
510k Number | K052950 |
Device Name: | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
Contact | Marci Halevi |
Correspondent | Marci Halevi ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-20 |
Decision Date | 2005-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024314276 | K052950 | 000 |
00889024314269 | K052950 | 000 |
00889024314252 | K052950 | 000 |
00889024314245 | K052950 | 000 |
00889024314238 | K052950 | 000 |
00889024314221 | K052950 | 000 |
00889024314214 | K052950 | 000 |
00889024314207 | K052950 | 000 |