FLEXIBLE REAMER WITH Multiple Flute TIP, 13.5 MM

Primary DI
M209223950
Brand
FLEXIBLE REAMER WITH Multiple Flute TIP, 13.5 MM
Company
BIOPRO, INC.
Model
22395
Published
2019-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163627000Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.2017-09-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209223950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209169570ACCU-CUT™ TWO STAGE169572015-09-16
M209169580ACCU-CUT™ TWO STAGE S169582015-09-16
M209173000ACCU-CUT™ 3mm OFFSET173002015-09-16
M209173060ACCU-CUT™ 3mm OFFSET S173062015-09-16
M209175020ACCU-CUT™ STANDARD W/2 BLADES175022015-09-16
M209175030ACCU-CUT™ 1mm OFFSET W/2 BLADES175032015-09-16
M209175040ACCU-CUT™ 2mm OFFSET W/2 BLADES175042015-09-16
M209175050ACCU-CUT™ 3mm OFFSET W/2 BLADES175052015-09-16
M209175060ACCU-CUT™ TWO STAGE W/2 BLADES175062015-09-16
M209177210ACCU-CUT™ STD MICRO CHOICE177212015-09-16
M209177330ACCU-CUT™ 1 mm MICRO CHOICE177332015-09-16
M209177340ACCU-CUT™ 2 mm MICRO CHOICE177342015-09-16
M209177350ACCU-CUT™ TWO STAGE MICRO177352015-09-16
M209185780ACCU-CUT™ 2mm W/THREADED K-WIRES185782015-09-16
M209195050ACCU-CUT™ STANDARD195052015-09-16
M209195060ACCU-CUT™ 1MM195062015-09-16
M209195070ACCU-CUT™ 2MM195072015-09-16
M209195080ACCU-CUT™ 3MM195082015-09-16
M209195090ACCU-CUT™ TWO STAGE195092015-09-16
M209195100ACCU-CUT™ LONG ARM195102015-09-16

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