LapiLock TN-LL-6505

GUDID 00840124506350

Fulcrum 5.0 mm

FUSION ORTHOPEDICS, LLC

Cannulated surgical drill bit, single-use, non-sterile
Primary Device ID00840124506350
NIH Device Record Key98522b90-4282-4647-91c8-3afa764ab6f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapiLock
Version Model NumberTN-LL-6505
Catalog NumberTN-LL-6505
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124506350 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


[00840124506350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-28
Device Publish Date2021-12-20

On-Brand Devices [LapiLock]

00840124501768Cutting Block Joint Seeker
00840124501751Cutting Block 5 & 7.5
00840124501744Sagittal Saw 40 mm
00840124501720Fenestration Drill 2.0 mm
00840124506039Olive Wire Threaded
00840124506091Folcrum 4.0 mm
00840124506084Folcrum 3.0mm
00840124506077Folcrum 2.0mm
00840124506114Cutting Block Right
00840124506107Cutting Block Left
00840124506381Short Driver 3.0 mm
00840124506374Olive Wire Short Thread
00840124506367Olive Wire Non-Threaded
00840124506350Fulcrum 5.0 mm
00840124506343Fulcrum Fix
00840124506336Fulcrum Fix Long
00840124506411Cutting Block Parallel
00840124506497Triplanar Correction System Jig Right
00840124501713Triplanar Correction System Jig Left
00840124506572YOCO Blade Double
00840124506565YOCO Single
00840124507029MP Olive Wire Non-Threaded
00840124507012MP Olive Wire Threaded
00840124507005LapiLock Metatarsal Bone Positioner
00840124507371YOCO Single Conmed
00840124507364YOCO Double Conmed
00840124507081YOCO Single Conmed
00840124507074YOCO Double Conmed
00840124508972Sagittal Saw, 40 mm
00840124510302Sagittal Saw Conmed 40mm
00840124510319Sagittal Saw Conmed 40mm Sterile
00840124510333YOCO Lapidus Single
00840124510326YOCO Lapidus Double
00840124511156LapiLock Bone Cut Guide Single Slot
00840124506480Met Cup Subcutaneous
00840124511361LapiLock Instrumentation Kit (No Implants Included)

Trademark Results [LapiLock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LAPILOCK
LAPILOCK
97382001 not registered Live/Pending
Fusion Orthopedics USA, LLC
2022-04-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.