Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium
FDA 510(k) K061384 · Walter Lorenz Surgical, Inc.
510(k) numberK061384
Submission
- Device name
- Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- May 18, 2006
- Decision date
- June 6, 2006
- 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 |
|---|---|---|
| K063386 | Lorenz Orthodontic Anchorage SystemOAT · Traditional | 02/09/2007SE |
| K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesJEY · Traditional | 01/12/2007SE |
| K063506 | Lorenz Sternal Closure SystemHRS · Special | 12/18/2006SE |
| K062842 | Twist DrillHBE · Traditional | 12/04/2006SE |
| K042516 | OtomimixNEA · Traditional | 11/08/2004SE |
| K030425 | Lorenz Resorbable Distraction System or ExpanderJEY · Traditional | 05/14/2004SE |
| K040990 | Modification to Self-Drilling Radiographic MarkersNEU · Special | 05/13/2004SE |
| K040983 | Lorenz Self-Drilling Imf ScrewDZE · Special | 05/05/2004SE |
| K033740 | Lorenz Sternal Closure SystemHWC · Special | 12/15/2003SE |
| K032228 | Lorenz 2.4 Self Drilling ScrewsHWC · Special | 08/11/2003SE |
Questions and answers
When was Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium cleared by the FDA?
Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium (K061384) received a 510(k) decision of Substantially Equivalent on June 6, 2006, 19 days after the submission was received.
What is the product code of K061384?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.