FDA.reportPublic FDA data

PONTiS Flexor Tendon Repair System

Primary DI
00859210006025
Brand
PONTiS Flexor Tendon Repair System
Company
PONTIS ORTHOPAEDICS, LLC
Model
400-3031
Catalog number
400-3031
Device description
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains:1x 3mm Anchor with Driver handleAnchor has size #3-0 multifilament SS sutureEach end of SS suture has pre-attached straight needles.Supplied pouched, sterilized with EO.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101126000
K133579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101126000PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPSCore Essence Orthopaedics, Inc.2010-12-02MBI
K133579000MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPSPontis Orthopaedics, LLC2014-06-26MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859210006025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859210006025008592100060258592100060250859210006025

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.5Millimeter
Outer Diameter3Millimeter

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
00859210006018PONTiS Flexor Tendon Repair System400-3014400-30142016-09-01
08592110006100PONTiS Suture-Crimp Implant400-3019400-30192016-11-18
00859210006049PONTiS Flexor Tendon Repar System400-3015400-30152016-09-01

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