Walter Lorenz Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 56
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Walter Lorenz Surgical, Inc. makes
Walter Lorenz Surgical, Inc. manufactures orthopedic and maxillofacial fixation devices, including mini bone plates and screws, distraction systems for mandibular and maxilla (Le Fort) bone growth, and pectus support bars. Their portfolio also covers surgical instruments like monopolar and bipolar cautery tools, as well as specialized implants such as lactosorb tap-free screws and a titanium stent. Additionally, they produce a xenon light source for surgical illumination and an otomix device for ear-related procedures.
The company’s devices are classified under FDA categories Class I and Class II, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance in the United States. The manufacturer operates from the US.
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
FDA recalls
FDA recall records list 3 recalls initiated by Walter Lorenz Surgical, Inc., initiated on 2006-02-17. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 17 Feb 2006 Z-0383-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much.
- 17 Feb 2006 Z-0384-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much.
- 17 Feb 2006 Z-0385-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much.
Frequently asked questions
How many devices does Walter Lorenz Surgical, Inc. have in the registry?
The registry currently lists 56 devices for Walter Lorenz Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Walter Lorenz Surgical, Inc.'s devices?
Among its 50 most recently registered devices, Walter Lorenz Surgical, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Walter Lorenz Surgical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Walter Lorenz Surgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Walter Lorenz Surgical, Inc.?
FDA recall records list 3 recalls initiated by Walter Lorenz Surgical, Inc., the most recent initiated on 2006-02-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Walter Lorenz Surgical, Inc. in the registry?
The most recently registered devices listed for Walter Lorenz Surgical, Inc. include LORENZ 1.0 MM SYSTEM, LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW, LORENZ EXTERNAL MANDIBULAR DISTRACTOR and STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS.