| Primary Device ID | M269FS10141 |
| NIH Device Record Key | 16f7ea33-326b-4e57-a2dd-d9ab8681a404 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ti6® Internal Fixation System |
| Version Model Number | FS1014 |
| Catalog Number | FS1014 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780244936 [Primary] |
| HIBCC | M269FS10141 [Secondary] |
| HTD | FORCEPS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
[M269FS10141]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2017-09-05 |
| M269FS40401 | Integra® Ti6® The removal driver shaft is used in conjunction with the Ti6 TH-series screws. |
| M269FS10401 | Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system. |
| M269FS10301 | Integra® Ti6® The forceps are used for screw pickup in the Integra Ti6 system. |
| M269FS10141 | Integra® Ti6® The Scarf Bone Reduction Forceps are used to hold objects in the Integra Ti6 sys |
| M269FS10121 | Integra® Ti6® The Bone Reduction Forceps are used to hold objects in the Integra Ti6 system. T |
| M269FS10101 | The Bone Reduction Forceps are used to hold objects in the Integra Ti6 system. These forceps hav |
| M269FS20601 | Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 a |
| M269FS20501 | Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 a |
| M269TT5000L1 | Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont |
| M269TT50001 | Integra® Ti6® TheTi6 Digital Fusion Instrument Sterilization Tray is designed to contain, secu |
| M269TT4000S1 | Integra® Ti6® The Ti6 sterilization tray, TH&TQ series instruments, is used to contain, secure |
| M269TT4000L1 | Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont |
| M269TT40001 | Integra® Ti6® TheTi6 TH & TQ Series Instrument Sterilization Tray is designed to contain, secu |
| M269TT3000L1 | Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont |
| M269TT30001 | Integra® Ti6® TheTi6 TC Series Instrument Sterilization Tray is designed to contain, secure, a |
| M269TT2000L1 | Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont |
| M269TT20001 | Integra® Ti6® TheTi6 TS Series Instrument Sterilization Tray is designed to contain, secure, a |
| M269TT1000L1 | Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont |
| M269TT10001 | Integra® Ti6® TheTi6 Sterilization Tray Base is the bottom portion wherein devices are placed. |
| M269TI6INSTP1 | Integra® Ti6® The Ti6 Base Instrument Set contains instruments used to aid in the implantation |
| M269FS20201 | Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 TS-series 3 |
| M269FS20101 | Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 TS-series 2 |
| M269FS20041 | Integra® Ti6® The drill bit is a cutting tool used to create 4.0 mm cylindrical holes. |
| M269FS20031 | Integra® Ti6® The drill bit is a cutting tool used to create 3.0 mm cylindrical holes. |
| M269FS20021 | Integra® Ti6® The drill bit is a cutting tool used to create 2.5 mm cylindrical holes. |
| M269FS20011 | Integra® Ti6® The drill bit is a cutting tool used to create 2.0 mm cylindrical holes. |
| M269DS30101 | Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 digital fus |
| M269DS10071 | Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws. |
| M269KW1102P1 | Integra® Ti6® The threaded guide wire is used as a guide for placement or insertion of a devic |
| M269FS21851 | Integra® Ti6® The Ti6 cannulated CounterSink is used to add space or clearance for the head of |
| M269FS21751 | Integra® Ti6® The Ti6 cannulated CounterSink is used to add space or clearance for the head of |
| M269DW11111 | Integra® Ti6® The smooth guide wire is used as a guide for placement or insertion of a device. |