The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for The Trabecular Metal Bone Stabilization Implant, Model 99-11197-xx-10.
| Device ID | K050101 |
| 510k Number | K050101 |
| Device Name: | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024306202 | K050101 | 000 |
| 00889024305977 | K050101 | 000 |
| 00889024305991 | K050101 | 000 |
| 00889024306011 | K050101 | 000 |
| 00889024306035 | K050101 | 000 |
| 00889024306066 | K050101 | 000 |
| 00889024306080 | K050101 | 000 |
| 00889024306103 | K050101 | 000 |
| 00889024306127 | K050101 | 000 |
| 00889024306141 | K050101 | 000 |
| 00889024306165 | K050101 | 000 |
| 00889024306189 | K050101 | 000 |
| 00889024305953 | K050101 | 000 |