The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Osi Q System Arthroscopes.
| Device ID | K133018 |
| 510k Number | K133018 |
| Device Name: | OSI Q SYSTEM ARTHROSCOPES |
| Classification | Arthroscope |
| Applicant | ORTHOPEDIC SCIENCES, INC 12264 EI CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas ORTHOPEDIC SCIENCES, INC 12264 EI CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813892021424 | K133018 | 000 |
| 00813892020649 | K133018 | 000 |
| 00813892020656 | K133018 | 000 |
| 00813892020663 | K133018 | 000 |
| 00813892020670 | K133018 | 000 |
| 00813892021080 | K133018 | 000 |
| 00813892021097 | K133018 | 000 |
| 00813892021103 | K133018 | 000 |
| 00813892021110 | K133018 | 000 |
| 00813892020632 | K133018 | 000 |