PONTiS Flexor Tendon Repair System

Primary DI
00859210006032
Brand
PONTiS Flexor Tendon Repair System
Company
PONTIS ORTHOPAEDICS, LLC
Model
401-3006
Catalog number
401-3006
Device description
PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains:1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures.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

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
00859210006032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859210006032008592100060328592100060320859210006032

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, multifilamentA sterile, multiple-strand (multifilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached needle intended to be disposed of after single use. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. 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
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
00859210006049PONTiS Flexor Tendon Repar System400-3015400-30152016-09-01

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