PEAK FX™PLATE 814230106
GUDID 00887868037191
Biomet Orthopedics, LLC
Hip internal fixation system| Primary Device ID | 00887868037191 |
| NIH Device Record Key | 131e2374-0b32-40d3-9788-c7e6cb52ad16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEAK FX™PLATE |
| Version Model Number | 8142-30-106 |
| Catalog Number | 814230106 |
| 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
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868037191 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063509
FDA Product Code
| HRS | Plate, fixation, bone |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
[00887868037191]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [PEAK FX™PLATE]
| 00887868037221 | 8142-30-112 |
| 00887868037214 | 8142-30-110 |
| 00887868037207 | 8142-30-108 |
| 00887868037191 | 8142-30-106 |
| 00887868037184 | 8142-30-104 |
| 00887868037177 | 8142-30-102 |
| 00887868037160 | 8142-30-012 |
| 00887868037153 | 8142-30-010 |
| 00887868037146 | 8142-30-008 |
| 00887868037139 | 8142-30-006 |
| 00887868037122 | 8142-30-004 |
| 00887868037115 | 8142-30-003 |
| 00887868037108 | 8142-30-002 |
Trademark Results [PEAK FX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEAK FX 78867976 not registered Dead/Abandoned |
DePuy, Inc. 2006-04-24 |
 PEAK FX 75923271 2587226 Dead/Cancelled |
Neways, Inc. 2000-02-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.