FDA.reportPublic FDA data

PONTiS Flexor Tendon Repar System

Primary DI
00859210006049
Brand
PONTiS Flexor Tendon Repar System
Company
PONTIS ORTHOPAEDICS, LLC
Model
400-3015
Catalog number
400-3015
Device description
"PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains:1x Pre-drill, size 0.063"" diameter x 4"" length1x Pre-drill, size 0.078"" diameter x 4"" length1x Pre-drill, size 0.094"" diameter x 4"" length> For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565)Supplied Non-Sterile. "
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859210006049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859210006049008592100060498592100060490859210006049

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Outer Diameter0.063Inch
Outer Diameter0.078Inch
Outer Diameter0.094Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
415-567-8935info@pontisorthopaedic.com

Regulatory Flags#

DUNS number
047775061
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859210006001PONTiS Flexor Tendon Repair System400-3011400-30112016-09-01
00859210006032PONTiS Flexor Tendon Repair System401-3006401-30062016-09-01
00859210006070PONTiS Achilles Tendon Repair System600-4001600-40012016-09-01
00859210006117PONTiS Suture-Crimp Implant400-3020400-30202017-09-12
00859210006018PONTiS Flexor Tendon Repair System400-3014400-30142016-09-01
08592110006100PONTiS Suture-Crimp Implant400-3019400-30192016-11-18
00859210006025PONTiS Flexor Tendon Repair System400-3031400-30312016-09-01

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