ORTHOSIZE
System, Image Processing, Radiological
ORTHOSIZE LLC
The following data is part of a premarket notification filed by Orthosize Llc with the FDA for Orthosize.
Pre-market Notification Details
| Device ID | K120115 |
| 510k Number | K120115 |
| Device Name: | ORTHOSIZE |
| Classification | System, Image Processing, Radiological |
| Applicant | ORTHOSIZE LLC 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Yarmela Pavlovic |
| Correspondent | Yarmela Pavlovic ORTHOSIZE LLC 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-03-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868306709 | K120115 | 000 |
Trademark Results [ORTHOSIZE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOSIZE 85133718 4358361 Live/Registered |
Biomet Manufacturing, LLC 2010-09-20 |
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