A.L.P.S.® Elbow System 131218704
GUDID 00887868532153
Biomet Orthopedics, LLC
Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile| Primary Device ID | 00887868532153 |
| NIH Device Record Key | b44d5185-b661-4c56-83cc-42b193a5aebd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A.L.P.S.® Elbow System |
| Version Model Number | 1312-18-704 |
| Catalog Number | 131218704 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868532153 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101421
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
[00887868532153]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-23 |
| Device Publish Date | 2021-08-13 |
On-Brand Devices [A.L.P.S.® Elbow System]
| 00887868435737 | 2312-18-001 |
| 00887868532221 | 1312-18-804 |
| 00887868532214 | 1312-18-803 |
| 00887868532207 | 1312-18-801 |
| 00887868532191 | 1312-18-800 |
| 00887868532184 | 1312-18-708 |
| 00887868532177 | 1312-18-707 |
| 00887868532160 | 1312-18-705 |
| 00887868532153 | 1312-18-704 |
| 00887868532108 | 1312-18-609 |
| 00887868532092 | 1312-18-607 |
| 00887868532085 | 1312-18-606 |
| 00887868532078 | 1312-18-604 |
| 00887868532009 | 1312-18-308 |
| 00887868531996 | 1312-18-305 |
| 00887868531941 | 1312-18-208 |
| 00887868531934 | 1312-18-207 |
| 00887868531927 | 1312-18-205 |
| 00887868531910 | 1312-18-204 |
Trademark Results [A.L.P.S.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A.L.P.S. 86414170 not registered Dead/Abandoned |
Biomet C.V. 2014-10-03 |
 A.L.P.S. 86122580 4795950 Live/Registered |
Biomet C.V. 2013-11-19 |
 A.L.P.S. 85887976 not registered Dead/Abandoned |
Biomet C.V. 2013-03-27 |
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