REDUCT® Headless Compression Screw System
Screw, Fixation, Bone
Skeletal Dynamics, Inc.
The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Reduct® Headless Compression Screw System.
Pre-market Notification Details
| Device ID | K201662 |
| 510k Number | K201662 |
| Device Name: | REDUCT® Headless Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-07-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841506117133 | K201662 | 000 |
| 00841506115726 | K201662 | 000 |
| 00841506116341 | K201662 | 000 |
Trademark Results [REDUCT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDUCT 87724529 not registered Live/Pending |
Skeletal Dynamics LLC 2017-12-18 |
 REDUCT 79041784 3472558 Live/Registered |
REDUCT, naamloze vennootschap 2007-06-08 |
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