PONTiS Flexor Tendon Repair System

Primary DI
00859210006018
Brand
PONTiS Flexor Tendon Repair System
Company
PONTIS ORTHOPAEDICS, LLC
Model
400-3014
Catalog number
400-3014
Device description
PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader KitEach Kit contains:1x Dilating catheter for tendon transfer and pulley dilation1x Funnel for tendon transfer1x SS threader for threading sutures through the catheter & funnelSupplied pouched, sterilized with EO.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081060000FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLC2008-12-24GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859210006018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859210006018008592100060188592100060180859210006018

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
047775061
Device count
1
Lot or batch
true
Expiration date on label
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
08592110006100PONTiS Suture-Crimp Implant400-3019400-30192016-11-18
00859210006025PONTiS Flexor Tendon Repair System400-3031400-30312016-09-01
00859210006049PONTiS Flexor Tendon Repar System400-3015400-30152016-09-01

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