Fuse ACP F8224-4314

GUDID 08800033351931

Fuse-ACP Fixed Self Drilling Screw ø4.35 X 14mm

SOLCO BIOMEDICAL CO.,LTD.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID08800033351931
NIH Device Record Key00d2c897-1134-438c-9c40-6a549264966e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuse ACP
Version Model NumberF8224-4314
Catalog NumberF8224-4314
Company DUNS687844241
Company NameSOLCO BIOMEDICAL CO.,LTD.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800033351931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

[08800033351931]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-24

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08800033351955Fuse-ACP Fixed Self Drilling Screw ø4.35 X 16mm
08800033351931Fuse-ACP Fixed Self Drilling Screw ø4.35 X 14mm
08800033351917Fuse-ACP Fixed Self Drilling Screw ø4.35 X 12mm
08800033351832Fuse-ACP Fixed Self Drilling Screw ø4.0 X 16mm
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08800033351764Fuse-ACP Anterior Cervical Plate 5Level 91mm
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08800033351702Fuse-ACP Anterior Cervical Plate 4Level 74mm
08800033351696Fuse-ACP Anterior Cervical Plate 4Level 70mm
08800033351689Fuse-ACP Anterior Cervical Plate 4Level 66mm
08800033351672Fuse-ACP Anterior Cervical Plate 4Level 62mm
08800033351665Fuse-ACP Anterior Cervical Plate 4Level 58mm
08800033351658Fuse-ACP Anterior Cervical Plate 4Level 54mm
08800033351641Fuse-ACP Anterior Cervical Plate 4Level 50mm
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08800033351603Fuse-ACP Anterior Cervical Plate 3Level 63mm
08800033351597Fuse-ACP Anterior Cervical Plate 3Level 60mm
08800033351580Fuse-ACP Anterior Cervical Plate 3Level 57mm
08800033351573Fuse-ACP Anterior Cervical Plate 3Level 54mm
08800033351566Fuse-ACP Anterior Cervical Plate 3Level 51mm
08800033351559Fuse-ACP Anterior Cervical Plate 3Level 48mm
08800033351542Fuse-ACP Anterior Cervical Plate 3Level 45mm
08800033351481Fuse-ACP Anterior Cervical Plate 2Level 42mm
08800033351474Fuse-ACP Anterior Cervical Plate 2Level 40mm
08800033351467Fuse-ACP Anterior Cervical Plate 2Level 38mm
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