PolyLock Midfoot MF-NL-3536

GUDID 00840124503540

Compression Screw 3.5mm x 36mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00840124503540
NIH Device Record Keyd7d70ac6-1ebc-4bbf-bab3-8867ede8a7b4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock Midfoot
Version Model NumberMF-NL-3536
Catalog NumberMF-NL-3536
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
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]
GS100840124503540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


[00840124503540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

On-Brand Devices [PolyLock Midfoot]

00840124502628Lapidus Plate Neutral Left
00840124502611Maverick Lapidus Plate 2mm Right
00840124502604Maverick Lapidus Plate 2mm Left
00840124502598Maverick Lapidus Plate Neutral Right
00840124502581Maverick Lapidus Plate Neutral Left
00840124502574Straight Plate Compression 8 Hole
00840124502567Straight Plate Compression 6 Hole
00840124502550Straight Plate Compression 5 Hole
00840124502543Straight Plate Static 4 Hole
00840124502536Straight Plate Compression 2 Hole
00840124502529Straight Plate Static 2 Hole
00840124502512Straight Plate Compression 2 Hole
00840124502659Lapidus Plate 1mm Right
00840124502642Lapidus Plate 1mm Left
00840124502635Lapidus Plate Neutral Right
00840124504899Lag Plate 4 Hole
00840124503137Tapper Threaded Locking Screw 2.7mm x 19mm
00840124503120Tapper Threaded Locking Screw 2.7mm x 18mm
00840124503113Tapper Threaded Locking Screw 2.7mm x 17mm
00840124503106Tapper Threaded Locking Screw 2.7mm x 16mm
00840124503090Tapper Threaded Locking Screw 2.7mm x 15mm
00840124503083Tapper Threaded Locking Screw 2.7mm x 14mm
00840124503076Tapper Threaded Locking Screw 2.7mm x 13mm
00840124503069Tapper Threaded Locking Screw 2.7mm x 12mm
00840124503052Tapper Threaded Locking Screw 2.7mm x 11mm
00840124503045Tapper Threaded Locking Screw 2.7mm x 10mm
00840124503038Tapper Threaded Locking Screw 2.7mm x 9mm
00840124503021Tapper Threaded Locking Screw 2.7mm x 8mm
00840124502956LisFranc Plate Small Left
00840124502949LisFranc Plate Small Right
00840124502932LisFranc Plate Medium Left
00840124502925LisFranc Plate Medium Right
00840124502918LisFranc Plate Large Left
00840124502901LisFranc Plate Large Right
00840124502895L-Plate Compression 6 Hole Right
00840124502888L-Plate Compression 6 Hole Right
00840124502871L-Plate Compression 5 Hole Left
00840124502864L-Plate Compression 5 Hole Right
00840124502857L-Plate Compression 4 Hole left
00840124502840L-Plate Compression 4 Hole Right
00840124502833MTP Dorsal Plate Revision Right 10 °
00840124502826MTP Dorsal Plate Revision Left 10 °
00840124502819MTP Dorsal Plate Revision Neutral Right
00840124502802MTP Dorsal Plate Revision Neutral Left
00840124502796MTP Dorsal Plate Large Right 10 °
00840124502789MTP Dorsal Plate Large Neutral Right
00840124502772MTP Dorsal Plate Large Left 10 °
00840124502765MTP Dorsal Plate Neutral Large Left
00840124502758MTP Dorsal Plate Small Right 10 °
00840124502741MTP Dorsal Plate Small Right Neutral

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