Search Results
Found 1 results
510(k) Data Aggregation
K Number
K170482Device Name
Spider Frame External Fixation System
Manufacturer
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
Date Cleared
2017-09-27
(223 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones.
Indications are:
1. Post-Traumatic joint contracture which has resulted in loss of range of motion
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction
6. Correction of bony or soft tissue deformities
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis
9. Infected fractures or nonunions,
Device Description
Not Found
Ask a Question
Page 1 of 1