Maxlock Extreme System
FDA 510(k) K132591 · Orthohelix Surgical Designs, Inc.
510(k) numberK132591
Submission
- Device name
- Maxlock Extreme System
- Applicant
- Orthohelix Surgical Designs, Inc.
Medina, OH, US - Received
- August 19, 2013
- Decision date
- September 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K142148 | Orthohelix Staple SystemJDR · Special | 08/21/2014SE |
| K141004 | Intraosseous Fixation SystemHTY · Special | 08/21/2014SE |
| K141301 | Maxlock Extreme Elbow Fracture SystemHRS · Traditional | 07/11/2014SE |
| K132733 | Orthohelix Syndesmosis Fixation DevicesHTN · Traditional | 01/03/2014SE |
| K130832 | Orthohelix Staple SystemJDR · Traditional | 08/15/2013SE |
| K131324 | Maxtorque Screw SystemHWC · Traditional | 05/31/2013SE |
| K123203 | Maxlock Extreme System Model MXLHRS · Traditional | 12/14/2012SE |
| K122005 | Maxlock Extreme SystemHRS · Special | 09/06/2012SE |
| K121437 | Mini Maxlock Extreme Plating SystemHRS · Special | 06/13/2012SE |
| K120165 | Intraosseous Fixation SystemHTY · Traditional | 04/17/2012SE |
Questions and answers
When was Maxlock Extreme System cleared by the FDA?
Maxlock Extreme System (K132591) received a 510(k) decision of Substantially Equivalent on September 17, 2013, 29 days after the submission was received.
What is the product code of K132591?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.