FDA.reportPublic FDA data

"0.035"" x 5"" K-Wire Standard"

Primary DI
M970210240040
Brand
"0.035"" x 5"" K-Wire Standard"
Company
Trilliant Surgical, LLC
Model
210-24-004
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M970210240040PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00810028399099Tiger201-40-2102024-06-04
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00850062461949Tibial Impactor Tips 920-0061-042024-08-09
00810028391840Arsenal Ankle340-00-0032022-05-02
00812926028804Hook Tamp320-00-0202019-03-11
008129260201293S Hemi111-00-0022018-09-23
008129260202283S Hemi111-00-0122018-09-23
00812926027043Two-Step Hammertoe214-00-0142018-09-23
008129260280333S Hemi111-00-0132018-09-23
00812926028187Staple Tamp510-00-0052018-09-23
00810028398344Tiger201-20-0082024-05-31
00810028395343Arsenal Foot300-82-0252024-03-27
00810028395206Arsenal Foot300-82-0112024-03-21
00810028395213Arsenal Foot300-82-0122024-03-21
00810028395220Arsenal Foot300-82-0132024-03-21
00810028395237Arsenal Foot300-82-0142024-03-21
00810028395244Arsenal Foot300-82-0152024-03-21
00810028395251Arsenal Foot300-82-0162024-03-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22
07630037864196APTUSMedartis AGHTY2024-03-22
07630037864226APTUSMedartis AGHTY2024-03-22
07630037864233APTUSMedartis AGHTY2024-03-22
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHHTY2024-02-06
07649990202082Handpiece SupraFuserSurgical Fusion Technologies GmbHHTY2024-02-05