ArcPhix System EXARC903028

GUDID B487EXARC9030280

ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.

EXSOMED CORPORATION

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Primary Device IDB487EXARC9030280
NIH Device Record Keydb66b1c1-8bb7-4a1e-9edc-5fb934cd2632
Commercial Distribution StatusIn Commercial Distribution
Brand NameArcPhix System
Version Model NumberEXARC903028
Catalog NumberEXARC903028
Company DUNS116722111
Company NameEXSOMED CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Dimensions

Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter
Length28 Millimeter
Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB487EXARC9030280 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2018-04-06

Devices Manufactured by EXSOMED CORPORATION

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B487EXINN9215080 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
B487EXINN9215090 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
B487EXINN9215100 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
B487EXINN9215110 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
B487EXINN9215120 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
B487EXINN9215130 - NanoPhix Implant2024-02-01 NanoPhix is a stainless steel bone screw.
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