CoLink® Mini Plating System
FDA 510(k) K191535 · In2bones USA, LLC
510(k) numberK191535
Submission
- Device name
- CoLink® Mini Plating System
- Applicant
- In2bones USA, LLC
Memphis, TN, US - Received
- June 10, 2019
- Decision date
- July 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | 05/30/2026SE |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list)HRS · Traditional | 08/13/2024SE |
| K233089 | NeoSpan® Compression Implant SystemHRS · Traditional | 05/24/2024SE |
| K231236 | IBS-B MIS Beveled Screw SystemHWC · Traditional | 07/27/2023SE |
| K213698 | CoLink PCR Plating SystemHRS · Traditional | 05/27/2022SE |
| K220260 | Hercules Syndesmosis Implant SystemHTN · Traditional | 03/31/2022SE |
| K212872 | Avenger Radial Head SystemKWI · Traditional | 12/17/2021SE |
| K213069 | CoLink NeoFuse Plating SystemHRS · Traditional | 12/13/2021SE |
| K212487 | CoLink Vallux Plating SystemHRS · Traditional | 11/18/2021SE |
| K203698 | CoLink Sfx Implant SystemHTY · Traditional | 05/04/2021SE |
Questions and answers
When was CoLink® Mini Plating System cleared by the FDA?
CoLink® Mini Plating System (K191535) received a 510(k) decision of Substantially Equivalent on July 29, 2019, 49 days after the submission was received.
What is the product code of K191535?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.