FDA.reportPublic FDA data

Plat Tip Adapter – Small

Primary DI
00810131881368
Brand
Plat Tip Adapter – Small
Company
Surgentec, LLC
Model
RED-NTA-09
Published
2025-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243580000GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC2025-02-05FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131881368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131881368008101318813688101318813680810131881368

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement ultrasonic surgical system handpiece tip, reusableA removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut orthopaedic cement upon contact during an orthopaedic surgical procedure (e.g., revision hip arthroplasty); it is not intended to cut body tissues. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for cement debris aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131882433ION-C Navigation LocatorSR12-25122026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSR12-65102026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSR12-65112026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSR12-65092026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSR21-63052026-07-06
00810131882556TiLink-L Navigation Drill GuideSR21-63012026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSR21-63042026-07-06
00810131882617TiLink-L Navigation Impact CapSR21-63032026-07-06
00810131882761Facet Sterile Implant - 55FI-S-552026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalFIC-10002026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSR12-27002026-07-06
00810131883669Ion Navigation Inserter AOSR12-65012026-07-06
00810131884772ION-C Final KitTI-C-10002026-07-06
00810131884871ION-C Navigation Reusable TraySR25-70052026-07-06
00810131884895ION-C ReusableSR25-10002026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySR25-10022026-07-06
00810131881061 BMAC Bevel Needle SR07-1500AAN-11-BMACS2025-01-03
00810131880941 BMAN Solid Diamond Needle SR07-1100AAN-09-BMANS2024-12-31
00810131880958 BMAN Solid Diamond Needle Kit SR07-1101AAN-09-BMAN2024-12-31
00810131880965BMAN Solid Diamond Needle - Two Pack SR07-1102AAN-09-2BMANS2024-12-31

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