FDA.reportPublic FDA data

Keyfix bone drill 9G

Primary DI
08058964727718
Brand
Keyfix bone drill 9G
Company
G21 SRL
Model
900204
Published
2024-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058964727718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058964727718080589647277188058964727718

GMDN Terms#

Term, Definition table
TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431529195
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058964728685KeyFix Direct Access Needle Trocar and bevel tip, 13 gauge9001062026-10-19
08058964729767Easy Winch 13 G, 15 mm9002222026-10-19
08058964729774Easy Winch 13 G, 10 mm9002212026-10-19
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mm9000259000252026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mm9000269000262026-09-30
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G9000302026-05-05
08058964729057Arthrex Bone Cement Closed Mixing Bowl AS-901-22024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe AS-901-32024-10-14
08058964729071Arthrex Bone Cement Syringe Gun, DisposableAS-901-42024-10-14
08058964727862SpaceFlex Knee Trial9002012024-10-10
08058964728654Arthrex Bone Cement Mixing Syringe AR-901-32024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlAR-901-12024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl AR-901-22024-10-14
08058964728760Arthrex Bone Cement Syringe Gun, DisposableAR-901-42024-10-14
08058964729217CeMend Shoulder SpacerAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerAR-902-10482025-12-19
08058964729248CeMend Shoulder SpacerAR-902-12482025-12-19
08058964729255CeMend Shoulder Spacer Reamer TrayAR-902-C12025-12-19
08058964729262Reamer T-handleAR-902-132025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886913330Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HTW2026-10-15
00889795150141APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
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
00190446960331DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960348DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
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
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21