Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K101421
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 · DePuy Orthopaedics, Inc. · decided 2010-06-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| A.L.P.S.® | 8513-18-707 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436154 |
| A.L.P.S.DISTAL HUMERAL MEDIAL PLATE | 8513-18-704 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130243 |
| A.L.P.S.DISTAL HUMERAL MEDIAL PLATE | 8513-18-707 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130267 |
| A.L.P.S.DISTAL HUMERAL LATERAL PLATE | 8513-18-208 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130311 |
| A.L.P.S.DISTAL HUMERAL MEDIAL PLATE | 8513-18-705 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130250 |
| A.L.P.S.® | 8513-18-607 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436079 |
| A.L.P.S.® | 8513-18-705 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436147 |
| A.L.P.S.® | 8513-18-204 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868435898 |
| A.L.P.S.DISTAL HUMERAL LATERAL PLATE | 8513-18-204 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130281 |
| A.L.P.S.® | 8513-18-208 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868435928 |
| A.L.P.S.® | 8513-18-604 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436055 |
| A.L.P.S.DISTAL HUMERAL MEDIAL PLATE | 8513-18-708 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130274 |
| A.L.P.S.OLECRANON PLATE - LEFT | 8513-18-607 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130342 |
| A.L.P.S.® | 8513-18-606 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436062 |
| A.L.P.S.DISTAL HUMERAL LATERAL PLATE | 8513-18-205 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130298 |
| A.L.P.S.OLECRANON PLATE - RIGHT | 8513-18-604 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130328 |
| A.L.P.S.DISTAL HUMERAL POSTERIOR LATERAL PLATE | 8513-18-308 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130236 |
| A.L.P.S.® | 8513-18-609 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436086 |
| A.L.P.S.DISTAL HUMERAL LATERAL PLATE | 8513-18-207 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130304 |
| A.L.P.S.® | 8513-18-205 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868435904 |
| A.L.P.S.® | 8513-18-305 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868435973 |
| A.L.P.S.® | 8513-18-704 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436130 |
| A.L.P.S.® | 8513-18-708 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868436161 |
| A.L.P.S.® | 8513-18-207 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868435911 |
| A.L.P.S.OLECRANON PLATE - RIGHT | 8513-18-606 | Biomet Orthopedics, LLC | HRS HTN HWC | 00887868130335 |