Whiteside Biomechanics, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Whiteside Biomechanics, Inc. makes
Whiteside Biomechanics, Inc. manufactures orthopedic implants including femoral components such as the Quatro M and QuatroLoc plasma-sprayed femoral components, bipolar and unipolar femoral heads (including ceramic and zirconia ceramic variants), acetabular systems like the Micro-Seal acetabular system, and knee systems such as the Symmetric Unicompartmental Knee System. The company also produces spinal systems, cancellous bone screws, and cable systems including low-profile stainless steel and titanium cables (Models BIO-1-1014 and BIO-1-1013).
All devices listed are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 1 recall initiated by Whiteside Biomechanics, Inc., initiated on 2006-09-15. By recorded status: 1 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
- 15 Sep 2006 Z-0316-2007 Unclassified (pre-2012) Terminated The soft tissue pin in the retractor can break off and become embedded in the tissue.
Frequently asked questions
How many devices does Whiteside Biomechanics, Inc. have in the registry?
The registry currently lists 13 devices for Whiteside Biomechanics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Whiteside Biomechanics, Inc.'s devices?
Among its 13 most recently registered devices, Whiteside Biomechanics, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Whiteside Biomechanics, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Whiteside Biomechanics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Whiteside Biomechanics, Inc.?
FDA recall records list 1 recall initiated by Whiteside Biomechanics, Inc., the most recent initiated on 15 Sep 2006. 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 Whiteside Biomechanics, Inc. in the registry?
The most recently registered devices listed for Whiteside Biomechanics, Inc. include QUATRO M FEMORAL COMPONENT, QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT, BIPOLAR FEMORAL HEAD and MICRO-SEAL ACETABULAR SYSTEM.