The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Guide.
| Device ID | K111558 |
| 510k Number | K111558 |
| Device Name: | SURGICASE GUIDE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-03 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060351105 | K111558 | 000 |
| 05420060351099 | K111558 | 000 |
| 05420060351082 | K111558 | 000 |
| 05420060350115 | K111558 | 000 |
| 05420060350108 | K111558 | 000 |