Primary Device ID | M268102031961 |
NIH Device Record Key | a16ef380-0d7d-4180-8cab-c90ff46d9375 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cadence™ |
Version Model Number | 10203196 |
Company DUNS | 942377524 |
Company Name | Ascension Orthopedics, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780240327 [Primary] |
HIBCC | M268102031961 [Secondary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
[M268102031961]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2016-08-24 |
M268102031961 | U-Joint is used to remove the Tibial Tray from the talus when the Slap Hammer is not sufficient. |
M268102030281 | Cadence Talar Implant Extractor is used to remove the Talar Dome implant from the implant site. |
M268102030071 | Cadence Insert Inserter is used to properly insert and position the insert implant on the anteri |
M268102095421 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095411 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095401 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095391 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095381 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095371 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095361 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095321 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095311 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095301 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095291 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095281 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095271 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102095261 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094421 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094411 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094401 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094391 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094381 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094371 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094361 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094321 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094311 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094301 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094291 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094281 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094271 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102094261 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093421 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093411 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M28102093401 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093391 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093381 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093371 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093361 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093321 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093311 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093301 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093291 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093281 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093271 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102093261 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102092421 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102092411 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102092401 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102092391 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |
M268102092381 | The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl |