The following data is part of a premarket notification filed by Jm Longyear Manufacturing, Llc D.b.a. Able Medical Devices with the FDA for Able Medical Devices Valkyrie Thoracic Fixation System.
Device ID | K202889 |
510k Number | K202889 |
Device Name: | Able Medical Devices Valkyrie Thoracic Fixation System |
Classification | Plate, Fixation, Bone |
Applicant | JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices 512 4th Street Gwinn, MI 49841 |
Contact | Wade Depas |
Correspondent | Nathan Wright Empirical Testing Corp 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-28 |
Decision Date | 2021-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810071390234 | K202889 | 000 |
00810071390005 | K202889 | 000 |
00810071390616 | K202889 | 000 |
00810071390609 | K202889 | 000 |
00810071390593 | K202889 | 000 |
00810071390630 | K202889 | 000 |
00810071390623 | K202889 | 000 |
00810071390586 | K202889 | 000 |
00810071390579 | K202889 | 000 |
00810071390562 | K202889 | 000 |
00810071390555 | K202889 | 000 |
00810071390548 | K202889 | 000 |
00810071390531 | K202889 | 000 |
00810071390012 | K202889 | 000 |
00810071390029 | K202889 | 000 |
00810071390036 | K202889 | 000 |
00810071390227 | K202889 | 000 |
00810071390241 | K202889 | 000 |
00810071390203 | K202889 | 000 |
00810071390197 | K202889 | 000 |
00810071390180 | K202889 | 000 |
00810071390173 | K202889 | 000 |
00810071390166 | K202889 | 000 |
00810071390159 | K202889 | 000 |
00810071390074 | K202889 | 000 |
00810071390067 | K202889 | 000 |
00810071390050 | K202889 | 000 |
00810071390043 | K202889 | 000 |
00810071390524 | K202889 | 000 |