FDA.reportPublic FDA data

Tendonesis Chamfer Reamer

Primary DI
09348215165208
Brand
Tendonesis Chamfer Reamer
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
242-152-035
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242477000Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.2025-05-12MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215165208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215165208093482151652089348215165208

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, Left121-20-7890L2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, Left121-20-7891L2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, Left121-20-7892L2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, Left121-20-7893L2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, Left121-20-7894L2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, Left121-20-7895L2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, Left121-20-7896L2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, Left121-20-7897L2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, Left121-20-7898L2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, Right121-20-7890R2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, Right121-20-7891R2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, Right121-20-7892R2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, Right121-20-7893R2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, Right121-20-7894R2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, Right121-20-7895R2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, Right121-20-7896R2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, Right121-20-7897R2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, Right121-20-7898R2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, Left121-20-7790LE2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, Left121-20-7791LE2026-06-09

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Primary DI, Brand, Company table
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08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
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08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024255SignexOSTEONIC CO.,Ltd.HXX2025-06-24