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FDA 510(k)

JuggerStitch Meniscal Repair Device

K-Number: K191459 · 2019-09-13

ApplicantBiomet, Inc.
Decision Date2019-09-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JuggerStitch Meniscal Repair Device is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K191459. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JuggerStitch Meniscal Repair Device?

JuggerStitch Meniscal Repair Device is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Biomet, Inc.. The 510(k) number is K191459.

When was JuggerStitch Meniscal Repair Device approved by the FDA?

JuggerStitch Meniscal Repair Device received FDA 510(k) clearance on 2019-09-13, under approval number K191459.

What company makes JuggerStitch Meniscal Repair Device?

JuggerStitch Meniscal Repair Device is manufactured by Biomet, Inc..

What is the FDA product code for JuggerStitch Meniscal Repair Device?

The FDA product code for JuggerStitch Meniscal Repair Device is MBI.

Related Clinical Trials

NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT04198870 MitraClip REPAIR MR Study ACTIVE_NOT_RECRUITING NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT07065760 University of Utah PS-IDE: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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