Link Small Bone Plates
FDA 510(k) K854825 · Link America, Inc.
510(k) numberK854825
Submission
- Device name
- Link Small Bone Plates
- Applicant
- Link America, Inc.
East Hanavor, NJ, US - Received
- December 3, 1985
- Decision date
- January 21, 1986
- 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 |
|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | 10/22/1997SE |
| K964458 | Ellis External Mini-Fixator SystemKTT · Traditional | 12/09/1996SE |
| K955296 | Link MP Reconstruction HipJDI · Traditional | 02/14/1996SE |
| K954186 | Sled Unicompartment Knee SystemHSX · Traditional | 01/26/1996SE |
| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
| K931572 | Link Ceramic Heads 14/16 X 32MMLZO · Traditional | 03/28/1994SE |
| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
| K914803 | Schwabe Radius PlatesHRS · Traditional | 04/28/1992SE |
| K895507 | Link Giebel Blade Plate SystemKTT · Traditional | 03/13/1990SE |
Questions and answers
When was Link Small Bone Plates cleared by the FDA?
Link Small Bone Plates (K854825) received a 510(k) decision of Substantially Equivalent on January 21, 1986, 49 days after the submission was received.
What is the product code of K854825?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.