FuzeFix Large TN-FX-7036

GUDID 00819034026173

5.5mm Guide 3.6mm and 2.0mm

FUSION ORTHOPEDICS, LLC

Surgical drill guide, single-use, non-sterile
Primary Device ID00819034026173
NIH Device Record Key55b82f1a-5425-422e-b2fa-eb1e9f9e08c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Large
Version Model NumberTN-FX-7036
Catalog NumberTN-FX-7036
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exemptfalse
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
GS100819034026173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034026173]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

On-Brand Devices [FuzeFix Large]

00819034028320Headless Screw HL 5.5mm x 45mm
00819034028313Cannulated Screw HD 5.5mm x 45mm
00819034027330FX Wire Sleeve 7.0mm
00819034027323FX Drill Sleeve 7.0mm
00819034027316FX Sleeve 5.5mm and 7.0mm
00819034027309FX Drill Sleeve 5.5mm
00819034027293FX Wire Sleeve 5.5mm
00819034027286Parallel Wire Guide HD 5.5mm
00819034027279Parallel Wire Guide HD 7.0mm
00819034027262Parallel Wire Guide HL 7.0mm
00819034026883Depth Gauge HL 5.5mm/7.0mm
00819034026876Depth Gauge HD 5.5mm/7.0mm
00819034026203Screw Holding Forceps Large
008190340261807.0mm Guide 4.9mm and 2.8mm
008190340261735.5mm Guide 3.6mm and 2.0mm
00819034025824Screw Extractor Rod 7.0mm
00819034025817Screw Extractor Rod 5.5mm
00819034025749Driver Torx 7.0mm
00819034025732Driver Torx 5.5mm
00819034025725Proximal Reamer Cannulated 7.0mm
00819034025718Proximal Reamer Cannulated 5.5mm
00819034025107K-Wire Threaded 2.0mm
00819034025022K-Wire Standard 2.0mm
00819034025015Tap Cannulated 7.0mm
00819034025008Tap Cannulated 5.5mm
00819034024964Driver Torx Removal 7.0mm
00819034024957Driver Torx Removal 5.5mm
00819034024940K-Wire Threaded 2.8mm
00819034024933K-Wire Threaded 1.6mm
00819034024926K-Wire Standard 2.8mm
00819034024919K-Wire Standard 1.6mm
00819034024865Proximal Reamer Headless 7.0mm
00819034024858Proximal Reamer Headless 5.5mm
00819034024834Calibrated Drill Cannulated 4.9mm
00819034024827Calibrated Drill Cannulated 3.6mm
00819034029686FX Parallel Wire Guide HL 5.5mm
00840124502253HD FT 5.5mm x 90mm
00840124502239HD FT 5.5mm x 80mm
00840124502222HD FT 5.5mm x 75mm
00840124502215HD FT 5.5mm x 70mm
00840124502208HD FT 5.5mm x 65mm
00840124502192HD FT 5.5mm x 60mm
00840124502185HD FT 5.5mm x 55mm
00840124502178HD FT 5.5mm x 50mm
00840124502161HD FT 5.5mm x 48mm
00840124502154HD FT 5.5mm x 46mm
00840124502147HD FT 5.5mm x 45mm
00840124502130HD FT 5.5mm x 44mm
00840124502123HD FT 5.5mm x 42mm
00840124502116HD FT 5.5mm x 40mm
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