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510(k) Data Aggregation
K Number
K033856Device Name
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
Manufacturer
Date Cleared
2005-01-07
(393 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
PETER STEVENS, MD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This pediatric surgical implant is designed for the following intended purposes:
- 1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt.
- 2. Thus to stabilize bone fragments to provide fracture alignment and stability; or
- 3. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.
Device Description
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