Class Class II

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743)

K252743 2025-12-22 Traditional
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Description

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device by Ethicon, Inc., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252743
Clearance Date2025-12-22
Clearance TypeTraditional
Product CodeGAM
Regulation Number878.4493

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