WishBone Medical Plate and Screw System
FDA 510(k) K180736 · Wishbone Medical, Inc.
510(k) numberK180736
Submission
- Device name
- WishBone Medical Plate and Screw System
- Applicant
- Wishbone Medical, Inc.
Warsaw, IN, US - Received
- March 22, 2018
- Decision date
- October 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K231461 | Smart Correction System (HA Half Pins)KTT · Special | 06/16/2023SE |
| K230527 | WishBone Medical Plate and Screw SystemHRS · Special | 03/29/2023SE |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half PinsKTT · Special | 06/06/2022SE |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateHRS · Traditional | 01/27/2022SE |
| K203467 | WishBone Medical Plate and Screw SystemHWC · Special | 12/23/2020SE |
| K193368 | Smart Correction SystemKTT · Traditional | 09/18/2020SE |
| K182704 | WishBone Guided Growth SystemOBT · Traditional | 06/25/2019SE |
| K173013 | WishBone K-Wire SystemHTY · Traditional | 12/14/2017SE |
Questions and answers
When was WishBone Medical Plate and Screw System cleared by the FDA?
WishBone Medical Plate and Screw System (K180736) received a 510(k) decision of Substantially Equivalent on October 4, 2018, 196 days after the submission was received.
What is the product code of K180736?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.