Atlas FDA

BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR

FDA 510(k) clearance K110145 · decided 2011-03-04

Clearance details

K-number
K110145
Device name
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2011-01-18
Decision date
2011-03-04
Days to decision
45 days
Clearance type
Traditional
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegrad recall (Z-1828-2016)Biomet, Inc.2016-05-26
REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, recall (Z-3109-2011)Biomet, Inc.2011-08-31

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16