PUMA System
Washer, Bolt Nut
Panther Orthopedics, Inc.
The following data is part of a premarket notification filed by Panther Orthopedics, Inc. with the FDA for Puma System.
Pre-market Notification Details
| Device ID | K171703 |
| 510k Number | K171703 |
| Device Name: | PUMA System |
| Classification | Washer, Bolt Nut |
| Applicant | Panther Orthopedics, Inc. 5279 Apennines Circle San Jose, CA 95138 |
| Contact | Kathryn Stecco |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-08 |
| Decision Date | 2018-03-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B671FA0017B0 | K171703 | 000 |
Trademark Results [PUMA System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PUMA SYSTEM 87776486 not registered Live/Pending |
Coaptech, LLC 2018-01-30 |
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