InFrame Implant EXINF922034

GUDID B487EXINF9220340

InFrame is a stainless steel bone screw.

Exsomed Corporation

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device IDB487EXINF9220340
NIH Device Record Key9888726d-f6a6-42fa-81ee-54febd921dee
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFrame Implant
Version Model NumberEXINF922034
Catalog NumberEXINF922034
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 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 Dimensions

Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter
Outer Diameter2 Millimeter
Length34 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB487EXINF9220340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-05
Device Publish Date2021-09-27

On-Brand Devices [InFrame Implant]

B487EXINF9220100InFrame is a stainless steel bone screw.
B487EXINF9220500InFrame is a stainless steel bone screw.
B487EXINF9220480InFrame is a stainless steel bone screw.
B487EXINF9220460InFrame is a stainless steel bone screw.
B487EXINF9220440InFrame is a stainless steel bone screw.
B487EXINF9220420InFrame is a stainless steel bone screw.
B487EXINF9220400InFrame is a stainless steel bone screw.
B487EXINF9220380InFrame is a stainless steel bone screw.
B487EXINF9220360InFrame is a stainless steel bone screw.
B487EXINF9220340InFrame is a stainless steel bone screw.
B487EXINF9220320InFrame is a stainless steel bone screw.
B487EXINF9220300InFrame is a stainless steel bone screw.
B487EXINF9220280InFrame is a stainless steel bone screw.
B487EXINF9220260InFrame is a stainless steel bone screw.
B487EXINF9220240InFrame is a stainless steel bone screw.
B487EXINF9220220InFrame is a stainless steel bone screw.
B487EXINF9220200InFrame is a stainless steel bone screw.
B487EXINF9220180InFrame is a stainless steel bone screw.
B487EXINF9220160InFrame is a stainless steel bone screw.
B487EXINF9220140InFrame is a stainless steel bone screw.
B487EXINF9220120InFrame is a stainless steel bone screw.

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