The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine & Trauma Navigation.
| Device ID | K183605 |
| 510k Number | K183605 |
| Device Name: | Spine & Trauma Navigation |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Alexander Schweirsch |
| Correspondent | Hugo Morales Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260583190017 | K183605 | 000 |
| 04056481113926 | K183605 | 000 |
| 04056481001049 | K183605 | 000 |
| 04056481001018 | K183605 | 000 |
| 04056481001292 | K183605 | 000 |
| 04056481001278 | K183605 | 000 |
| 04056481001261 | K183605 | 000 |
| 04056481001254 | K183605 | 000 |
| 04056481001247 | K183605 | 000 |
| 04056481001230 | K183605 | 000 |
| 04056481001223 | K183605 | 000 |
| 04056481001216 | K183605 | 000 |
| 04056481001209 | K183605 | 000 |
| 04056481001193 | K183605 | 000 |
| 04056481001186 | K183605 | 000 |
| 04056481001179 | K183605 | 000 |
| 04056481001162 | K183605 | 000 |
| 04056481145217 | K183605 | 000 |
| 04056481113933 | K183605 | 000 |
| 04056481113940 | K183605 | 000 |
| 04056481140144 | K183605 | 000 |
| 04056481139087 | K183605 | 000 |
| 04056481140427 | K183605 | 000 |
| 04056481139346 | K183605 | 000 |
| 04056481142025 | K183605 | 000 |
| 04056481141998 | K183605 | 000 |
| 04056481141837 | K183605 | 000 |
| 04056481141370 | K183605 | 000 |
| 04056481142018 | K183605 | 000 |
| 04056481142520 | K183605 | 000 |
| 04056481143718 | K183605 | 000 |
| 04056481143923 | K183605 | 000 |
| 04056481143947 | K183605 | 000 |
| 04056481143930 | K183605 | 000 |
| 04056481140359 | K183605 | 000 |
| 04056481140342 | K183605 | 000 |
| 04056481113957 | K183605 | 000 |
| 04056481006303 | K183605 | 000 |