FDA.reportPublic FDA data

InFrame Implant

Primary DI
B487EXINF9220180
Brand
InFrame Implant
Company
Exsomed Corporation
Model
EXINF922018
Catalog number
EXINF922018
Device description
InFrame is a stainless steel bone screw.
Published
2021-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201430000InFrame™ Cannulated Fixation SystemExsomed Corp.2020-06-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B487EXINF9220180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116722111
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B487EXINN9215060NanoPhix ImplantEXINN921506EXINN9215062022-11-01
B487EXINN9215070NanoPhix ImplantEXINN921507EXINN9215072022-11-01
B487EXINN9215080NanoPhix ImplantEXINN921508EXINN9215082022-11-01
B487EXINN9215090NanoPhix ImplantEXINN921509EXINN9215092022-11-01
B487EXINN9215100NanoPhix ImplantEXINN921510EXINN9215102022-11-01
B487EXINN9215110NanoPhix ImplantEXINN921511EXINN9215112022-11-01
B487EXINN9215120NanoPhix ImplantEXINN921512EXINN9215122022-11-01
B487EXINN9215130NanoPhix ImplantEXINN921513EXINN9215132022-11-01
B487EXINN9215140NanoPhix ImplantEXINN921514EXINN9215142022-11-01
B487EXINN9215150NanoPhix ImplantEXINN921515EXINN9215152022-11-01
B487EXINN9215160NanoPhix ImplantEXINN921516EXINN9215162022-11-01
B487EXINN9215170NanoPhix ImplantEXINN921517EXINN9215172022-11-01
B487EXINN9215180NanoPhix ImplantEXINN921518EXINN9215182022-11-01
B487EXINN9215190NanoPhix ImplantEXINN921519EXINN9215192022-11-01
B487EXINN9215200NanoPhix ImplantEXINN921520EXINN9215202022-11-01
B487EXINN9215210NanoPhix ImplantEXINN921521EXINN9215212022-11-01
B487EXINN9215220NanoPhix ImplantEXINN921522EXINN9215222022-11-01
B487EXINN9215230NanoPhix ImplantEXINN921523EXINN9215232022-11-01
B487EXINN9215240NanoPhix ImplantEXINN921524EXINN9215242022-11-01
B487EXINN9215250NanoPhix ImplantEXINN921525EXINN9215252022-11-01

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