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510(k) Data Aggregation
K Number
K113383Device Name
XTRAFIX EXTERNAL FIXATION SYSTEM
Manufacturer
EXTRAORTHO, INC.
Date Cleared
2012-06-26
(223 days)
Product Code
KTT, JDW
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EXTRAORTHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems; o
- Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0
Device Description
The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.
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