FDA.reportPublic FDA data

Drill Bit Blue 2.0mm 115mm AO

Primary DI
M209226800
Brand
Drill Bit Blue 2.0mm 115mm AO
Company
BIOPRO, INC.
Model
226780
Published
2019-12-17
Public version status
New
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162674000BioPro Foot Plating SystemsBiopro, Inc.2017-06-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209226800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use 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
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00889795150158APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795151728APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00190446960324DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
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00190446960409DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960416DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00889024715271Affixus®Zimmer, Inc.HTW2026-10-06
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
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