FuzeFix™ Twist Off FX-TW-2513

GUDID 00819034021765

TW 2.5mm x 13mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00819034021765
NIH Device Record Key9ab6e9df-8021-4682-af07-0794e2ffd402
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix™ Twist Off
Version Model NumberFX-TW-2513
Catalog NumberFX-TW-2513
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
GS100819034021765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034021765]

Moist Heat or Steam Sterilization


[00819034021765]

Moist Heat or Steam Sterilization


[00819034021765]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-06

On-Brand Devices [FuzeFix™ Twist Off]

00819034021826TW 2.5mm x 22mm
00819034021819TW 2.5mm x 20mm
00819034021802TW 2.5mm x 18mm
00819034021796TW 2.5mm x 16mm
00819034021789TW 2.5mm x 15mm
00819034021772TW 2.5mm x 14mm
00819034021765TW 2.5mm x 13mm
00819034021758TW 2.5mm x 12mm
00819034021741TW 2.5mm x 11mm
00819034021734TW 2.5mm x 10mm
00819034021727TW 2.0mm x 22mm
00819034021710TW 2.0mm x 20mm
00819034021703TW 2.0mm x 18mm
00819034021697TW 2.0mm x 16mm
00819034021680TW 2.0mm x 15mm
00819034021673TW 2.0mm x 14mm
00819034021666TW 2.0mm x 13mm
00819034021659TW 2.0mm x 12mm
00819034021642TW 2.0mm x 11mm
00819034021635TW 2.0mm x 10mm

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