The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Walterlorenz Surgical Assist Arm Scope Holder.
| Device ID | K190576 |
| 510k Number | K190576 |
| Device Name: | WalterLorenz Surgical Assist Arm Scope Holder |
| Classification | Endoscope Holder |
| Applicant | Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Contact | Lauren Jasper |
| Correspondent | Lauren Jasper Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Product Code | OCV |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036240448 | K190576 | 000 |