ORTHOLOC™ 2 LapiFuse™
GUDID 00889797076821
WRIGHT MEDICAL TECHNOLOGY, INC.
Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable| Primary Device ID | 00889797076821 |
| NIH Device Record Key | afc33738-6600-47f4-b66d-49953ba76ee8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOLOC™ 2 LapiFuse™ |
| Version Model Number | 3814102R |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, INC. |
| 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 | true |
| 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)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889797076821 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190670
FDA Product Code
| HRS | Plate, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
On-Brand Devices [ORTHOLOC™ 2 LapiFuse™]
| 00889797077835 | 38S40006 |
| 00889797077828 | 38S4102R |
| 00889797077811 | 38S4102L |
| 00889797077804 | 38S4002R |
| 00889797077798 | 38S4002L |
| 00889797077781 | 38S4100R |
| 00889797077774 | 38S4100L |
| 00889797077767 | 38S4000R |
| 00889797077750 | 38S4000L |
| 00889797076821 | 3814102R |
| 00889797076814 | 3814102L |
| 00889797076807 | 3814100R |
| 00889797076791 | 3814100L |
| 00889797076784 | 3814002R |
| 00889797076777 | 3814002L |
| 00889797076746 | 3814000R |
| 00889797076739 | 3814000L |
| 00889797076722 | 38140006 |
| 00889797076715 | 38140004 |
| 00889797076708 | 38140003 |
| 00889797076685 | 38140001 |
| 00889797076692 | Lapidus Hintermann Distractor |
Trademark Results [ORTHOLOC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOLOC 77636931 4222143 Live/Registered |
Wright Medical Technology, Inc. 2008-12-19 |
 ORTHOLOC 73596966 1417357 Live/Registered |
DOW CORNING CORPORATION 1986-05-05 |
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