The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Trabecular Metal Glenoid-bigliani/flatow The Complete Shoulder Solution, Model 4306.
| Device ID | K022377 |
| 510k Number | K022377 |
| Device Name: | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-22 |
| Decision Date | 2002-12-10 |
| Summary: | summary |