Primary Device ID | 00840124507012 |
NIH Device Record Key | 914cc3a3-b9c2-46fc-9adb-bba06c32d0b5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LapiLock |
Version Model Number | CD-LL-0990 |
Company DUNS | 080307067 |
Company Name | FUSION 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 | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840124507012 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
[00840124507012]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-13 |
Device Publish Date | 2022-09-05 |
00840124501768 | Cutting Block Joint Seeker |
00840124501751 | Cutting Block 5 & 7.5 |
00840124501744 | Sagittal Saw 40 mm |
00840124501720 | Fenestration Drill 2.0 mm |
00840124506039 | Olive Wire Threaded |
00840124506091 | Folcrum 4.0 mm |
00840124506084 | Folcrum 3.0mm |
00840124506077 | Folcrum 2.0mm |
00840124506114 | Cutting Block Right |
00840124506107 | Cutting Block Left |
00840124506381 | Short Driver 3.0 mm |
00840124506374 | Olive Wire Short Thread |
00840124506367 | Olive Wire Non-Threaded |
00840124506350 | Fulcrum 5.0 mm |
00840124506343 | Fulcrum Fix |
00840124506336 | Fulcrum Fix Long |
00840124506411 | Cutting Block Parallel |
00840124506497 | Triplanar Correction System Jig Right |
00840124501713 | Triplanar Correction System Jig Left |
00840124506572 | YOCO Blade Double |
00840124506565 | YOCO Single |
00840124507029 | MP Olive Wire Non-Threaded |
00840124507012 | MP Olive Wire Threaded |
00840124507005 | LapiLock Metatarsal Bone Positioner |
00840124507371 | YOCO Single Conmed |
00840124507364 | YOCO Double Conmed |
00840124507081 | YOCO Single Conmed |
00840124507074 | YOCO Double Conmed |
00840124508972 | Sagittal Saw, 40 mm |
00840124510302 | Sagittal Saw Conmed 40mm |
00840124510319 | Sagittal Saw Conmed 40mm Sterile |
00840124510333 | YOCO Lapidus Single |
00840124510326 | YOCO Lapidus Double |
00840124511156 | LapiLock Bone Cut Guide Single Slot |
00840124506480 | Met Cup Subcutaneous |
00840124511361 | LapiLock Instrumentation Kit (No Implants Included) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LAPILOCK 97382001 not registered Live/Pending |
Fusion Orthopedics USA, LLC 2022-04-26 |