The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Knee Arthroscopy.
| Device ID | K093118 |
| 510k Number | K093118 |
| Device Name: | BRAINLAB KNEE ARTHROSCOPY |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481002305 | K093118 | 000 |
| 04056481002299 | K093118 | 000 |