Bone Plate
FDA 510(k) K870082 · Terray Manufacturing, Inc.
510(k) numberK870082
Submission
- Device name
- Bone Plate
- Applicant
- Terray Manufacturing, Inc.
Ontario K7s 1l8, CA - Received
- January 8, 1987
- Decision date
- May 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K910874 | Thoracic Anterior Spinal Fixation PlateKWQ · Traditional | 02/03/1992SE |
| K882934 | Casf Cancellous Bone Screw, BT650HWC · Traditional | 10/13/1988SE |
| K882871 | Casf Drill Guide DG 170LYQ · Traditional | 09/23/1988SN |
| K883193 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K883125 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K870085 | Anterior Spinal Fixation PlateKWP · Traditional | 06/30/1987SE |
| K870083 | Ferray ExtractorHWB · Traditional | 02/26/1987SE |
| K870084 | RD 140 Surgical BenderHXW · Traditional | 01/28/1987SE |
Questions and answers
When was Bone Plate cleared by the FDA?
Bone Plate (K870082) received a 510(k) decision of Substantially Equivalent on May 6, 1987, 118 days after the submission was received.
What is the product code of K870082?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.