(48 days)
The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.
ULTiMAX™ Trochanteric Intramedullary Rod System II
The provided text is an FDA 510(k) clearance letter for a medical device called the "ULTiMAX™ Trochanteric Intramedullary Rod System II". This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information about acceptance criteria or the study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a detailed technical report or a clinical study summary.
Therefore, I cannot provide the requested information based only on the provided input. The document's purpose is to grant market authorization based on substantial equivalence, not to detail the specific performance validation results.
To answer your request, I would need a different type of document, such as:
- A pre-market submission summary (e.g., a 510(k) summary or an IDE report)
- A clinical study report
- A peer-reviewed publication about the device's performance
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.