The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Metrx System.
| Device ID | K993021 |
| 510k Number | K993021 |
| Device Name: | METRX SYSTEM |
| Classification | Arthroscope |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Roger N White |
| Correspondent | Roger N White SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-08 |
| Decision Date | 1999-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978085609 | K993021 | 000 |
| 00673978085593 | K993021 | 000 |
| 00673978085524 | K993021 | 000 |
| 00673978085517 | K993021 | 000 |
| 00673978085487 | K993021 | 000 |
| 00673978085456 | K993021 | 000 |
| 00721902949180 | K993021 | 000 |
| 00721902663444 | K993021 | 000 |
| 00721902444104 | K993021 | 000 |