| Primary Device ID | M269CSK5010011 |
| NIH Device Record Key | 23e9b901-5f82-4d17-859b-dc796d53ade4 |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Construct ™ |
| Version Model Number | CSK-5010-01 |
| Catalog Number | CSK501001 |
| 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 | true |
| 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 |
| 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 | 10381780244226 [Primary] |
| HIBCC | M269CSK5010011 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
[M269CSK5010011]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2017-08-30 |
| M269GS8661101 | Construct® Ankle Fusion Plate System The forceps are used for screw holding in the Construct A |
| M269LDG5010651 | Construct® Ankle Fusion Plate System The locking drill guide is used for precision and accurac |
| M269LDG5010451 | Construct® Ankle Fusion Plate System The locking drill guide is used for precision and accurac |
| M269GTS1000011 | Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide p |
| M269DDG5010011 | Construct® Ankle Fusion Plate System The double drill guide is used for precision and accuracy |
| M269CDG5010011 | Construct® Ankle Fusion Plate System The compression drill guide is used for precision and accu |
| M269CSA50100041 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating Block Assembly is a s |
| M269CSA50100031 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating Lid Block is the top p |
| M269CSA50100021 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating System Tray Base is th |
| M269CSA10000011 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating Insert is a separate r |
| M269CSA000121 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating System Lid is the top |
| M269DRL5010501 | Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrica |
| M269DRL5010321 | Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrica |
| M269DRL1000321 | Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrica |
| M269TSS5010011 | Construct® Ankle Fusion Plate System The TX 25 driver shaft with quick connect is used with t |
| M269PDG5010011 | Construct® Ankle Fusion Plate System The depth gauge for plate screws is a tool used to measur |
| M269PBH5010011 | Construct® Ankle Fusion Plate System The Plate Bending Handles are used to bend pre-countored |
| M269GTB1000021 | Construct® Ankle Fusion Plate System The right guide pin targeting base is used in the Constru |
| M269GTB1000011 | Construct® Ankle Fusion Plate System The left guide pin targeting base is used in the Construc |
| M269CSK5010011 | Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating System Countersink wit |