FDA.reportPublic FDA data

BIXCUT

Primary DI
04546540145871
Brand
BIXCUT
Company
Stryker GmbH
Model
0227-8115
Catalog number
0227-8115
Device description
IM Reamer, mod. Trinkle Fitting
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123604000ABG III MONOLITHIC HIP STEMHowmedica Osteonics Corp.2013-08-16MAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540145871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540145871045465401458714546540145871

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length480Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327616859HOFFMANN LRF4936-0-1304936-0-1302026-07-23
07613327616880HOFFMANN LRF4936-1-3054936-1-3052026-07-23
07613327649109T2, PANGEA5431405431402025-09-25
07613327649130T2, PANGEA5431705431702025-09-25
07613327649253T2, PANGEA6497-1-0606497-1-0602025-09-25
07613327649260T2, PANGEA6497-1-0706497-1-0702025-09-25
07613327649277T2, PANGEA6497-1-070S6497-1-070S2025-09-25
07613327649284T2, PANGEA6497-1-060S6497-1-060S2025-09-25
07613327649291T2, PANGEA6497-1-0806497-1-0802025-09-25
07613327649307T2, PANGEA6497-1-0906497-1-0902025-09-25
07613327649314T2, PANGEA6497-1-080S6497-1-080S2025-09-25
07613327649321T2, PANGEA6497-1-090S6497-1-090S2025-09-25
07613327649338T2, PANGEA6497-1-1006497-1-1002025-09-25
07613327649345T2, PANGEA6497-1-1106497-1-1102025-09-25
07613327649352T2, PANGEA6497-1-100S6497-1-100S2025-09-25
07613327649369T2, PANGEA6497-1-110S6497-1-110S2025-09-25
07613327649376T2, PANGEA6497-1-1306497-1-1302025-09-25
07613327649383T2, PANGEA6497-1-130S6497-1-130S2025-09-25
07613327649390T2, PANGEA6497-1-120S6497-1-120S2025-09-25
07613327649406T2, PANGEA6497-1-1206497-1-1202025-09-25

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Primary DI, Brand, Company table
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00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
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B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
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