Lorenz Sternal Closure System
FDA 510(k) K033740 · Walter Lorenz Surgical, Inc.
510(k) numberK033740
Submission
- Device name
- Lorenz Sternal Closure System
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- November 28, 2003
- Decision date
- December 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 |
| K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumHRS · Special | 06/06/2006SE |
| 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 |
| K032228 | Lorenz 2.4 Self Drilling ScrewsHWC · Special | 08/11/2003SE |
Questions and answers
When was Lorenz Sternal Closure System cleared by the FDA?
Lorenz Sternal Closure System (K033740) received a 510(k) decision of Substantially Equivalent on December 15, 2003, 17 days after the submission was received.
What is the product code of K033740?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.