Company · GB
Biomet UK Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2020. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2020 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling Biomet UK, Ltd., GB | LZO |
| Feb 27, 2020 | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads Biomet UK, Ltd., GB | LZO |
| Mar 28, 2014 | K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) Biomet UK, Ltd. | HRY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2018 | Biomet UK Ltd. HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate
Item Number: 2110-140-004
Product Usage:
The HipLOC Compression Hip Screw may be used primarily for fixation of Terminated |
JDO | K080685 |
| Aug 9, 2018 | Biomet UK Ltd. HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate
Item Number: 2110-135-004
Product Usage:
The HipLOC Compression Hip Screw may be used primarily for fixation of b Terminated |
JDO | K080685 |
| Aug 9, 2018 | Biomet UK Ltd. HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 3 Hole Plate
Item Number: 2110-135-003
Product Usage:
The HipLOC Compression Hip Screw may be used primarily for fixation of Terminated |
JDO | K080685 |
| Aug 9, 2018 | Biomet UK Ltd. HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate
Item Number: 2110-130-004
Product Usage:
The HipLOC Compression Hip Screw may be used primarily for fixation of Terminated |
JDO | K080685 |