The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Metrx System.
| Device ID | K002931 |
| 510k Number | K002931 |
| Device Name: | METRX SYSTEM |
| Classification | Arthroscope |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-20 |
| Decision Date | 2000-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074210353 | K002931 | 000 |