510(k) K080088 ยท HWC Screw, Fixation, Bone
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
| Applicant | Biomet Manufacturing, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 11, 2008 |
| Received | Jan 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2015 | Biomet, Inc. Ziploop Button
Product Usage:
The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease Terminated |
JDR | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905463, 2.9 mm Micromax Anchor Long Shaft, Size 2 Blue/White Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medi Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tis Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft T Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue An Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Device Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905581, 6.8 mm Lactoscrew 2#2 MB wI NDL, (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring De Terminated |
HWC | None listed |
| Mar 21, 2012 | Biomet, Inc. REF 905948, 2.MM Hitch Suture (Lactosorb Anchor L15 2#1,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.