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510(k) Data Aggregation
(86 days)
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.
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The provided document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a notification of the FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing Triage Medical, Inc. to market the device. It focuses on regulatory compliance, general controls, and classification.
Therefore, I cannot provide the requested information based on the input document. The document primarily addresses regulatory clearance rather than detailed performance study results.
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