Name: Predicase
Price: 199 USD

K-number	K232005
Device name	HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
Applicant	Smith & Nephew, Inc.
Product code	MBI
Device class	Class II
Decision date	Aug 4, 2023
Decision	Substantially Equivalent
Regulation	888.3040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)

Everything you need for a 510(k) submission. Nothing you don't.