Atlas FDA

BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS

FDA 510(k) clearance K080088 · decided 2008-06-11

Clearance details

K-number
K080088
Device name
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
Applicant
Biomet Manufacturing, Inc.
Decision
Substantially Equivalent
Date received
2008-01-14
Decision date
2008-06-11
Days to decision
149 days
Clearance type
Traditional
Product code
HWC
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
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to ai recall (Z-1364-2015)Biomet, Inc.2015-04-02
REF 905463, 2.9 mm Micromax Anchor Long Shaft, Size 2 Blue/White Maxbraid (Lactosorb L-15 recall (Z-1231-2012)Biomet, Inc.2012-03-21
REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable copo recall (Z-1232-2012)Biomet, Inc.2012-03-21
REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable recall (Z-1233-2012)Biomet, Inc.2012-03-21
REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer recall (Z-1234-2012)Biomet, Inc.2012-03-21
REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, E recall (Z-1235-2012)Biomet, Inc.2012-03-21
REF 905581, 6.8 mm Lactoscrew 2#2 MB wI NDL, (Lactosorb L-15 resorbable copolymer ) Steril recall (Z-1236-2012)Biomet, Inc.2012-03-21
REF 905948, 2.MM Hitch Suture (Lactosorb Anchor L15 2#1,(Lactosorb L-15 resorbable copolym recall (Z-1237-2012)Biomet, Inc.2012-03-21