DynaClip® Bone Staple
Staple, Fixation, Bone
MedShape, Inc.
The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynaclip® Bone Staple.
Pre-market Notification Details
| Device ID | K220812 |
| 510k Number | K220812 |
| Device Name: | DynaClip® Bone Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | MedShape, Inc. 1575 Northside Dr. NW, Suite 440 Atlanta, GA 30318 |
| Contact | Courtney Kline |
| Correspondent | Courtney Kline MedShape, Inc. 1575 Northside Dr. NW, Suite 440 Atlanta, GA 30318 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-08-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9703000112216160 | K220812 | 000 |
| M9703000111816160 | K220812 | 000 |
| M970300010321614120 | K220812 | 000 |
| M970300010281614120 | K220812 | 000 |
| M970300010241614120 | K220812 | 000 |
| M9703000112220200 | K220812 | 000 |
Trademark Results [DynaClip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNACLIP 87431215 not registered Dead/Abandoned |
MN Fastener Company LLC 2017-04-30 |
 DYNACLIP 86925549 5740102 Live/Registered |
MedShape, Inc. 2016-03-02 |
 DYNACLIP 79143736 4658173 Live/Registered |
DYNAenergetics GmbH & Co. KG 2013-09-05 |
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