DEVICE: PONTiS Achilles Tendon Repair System (00859210006070)
Device Identifier (DI) Information
PONTiS Achilles Tendon Repair System
600-4001
In Commercial Distribution
600-4001
PONTIS ORTHOPAEDICS, LLC
600-4001
In Commercial Distribution
600-4001
PONTIS ORTHOPAEDICS, LLC
PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.
Each Kit contains:
1x size #3 MFSS suture with 2 curved needles (white wrap)
1x size #3 MFSS suture with 2 curved needles (black wrap)
1x SS Crimp Collar for #3 SS sutures
Supplied pouched, sterilized with EO.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
13904 | Metallic suture, multifilament |
A 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Size #3 Suture |
Device Record Status
93cd59fc-c656-45e8-9757-5007351a9220
February 05, 2021
4
September 01, 2016
February 05, 2021
4
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
415-567-8935
info@pontisorthopaedics.com
info@pontisorthopaedics.com