PEAK FX™PLATE 814230106
GUDID 00887868037191
Biomet Orthopedics, LLC
Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system 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 |
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