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510(k) Data Aggregation
K Number
K024022Device Name
OSTEO-CABLE SLEEVE
Manufacturer
Date Cleared
2003-01-23
(49 days)
Product Code
Regulation Number
888.4540Why did this record match?
Product Code :
HXN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as:
- Femur And Tibial Fractures .
- Prophylactic Banding .
- Trochanteric Reattachment .
- Olecranon Fractures ●
- Patella Fractures ●
- Ankle Fractures ●
- Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques .
- Sternum Fixation After Open Heart Surgery ●
- Stabilization Of Cortical Onlay Strut Graft .
Device Description
The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.
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