Viper® Distal Volar Radius Plating System 27142716
GUDID M248271427161
The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
Ascension Orthopedics, Inc.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | M248271427161 |
| NIH Device Record Key | a5feb5da-231e-4e5f-a345-b7e0a2bfbf5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Viper® Distal Volar Radius Plating System |
| Version Model Number | 27142716 |
| Catalog Number | 27142716 |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
Customer Support Contacts
Device Dimensions
| 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 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 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780064954 [Primary] |
| HIBCC | M248271427161 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041461
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
[M248271427161]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [Viper® Distal Volar Radius Plating System]
| M2486000111 | 1.1MM K-WIRE |
| M2486050271 | VIPER/VALT 2.7MM DRILL BIT |
| M2486050201 | VIPER/VALT 2.0MM DRILL BIT |
| M2486050021 | VALT KEY LOCK DRIVER |
| M2486050011 | VALT PLACEMENT DRIVER |
| M248281350161 | The Viper cortical titanium screw, which is placed proximally. |
| M248281350121 | The Viper cortical titanium screw, which is placed proximally. |
| M248280066011 | The Viper distal volar radius plate consists of six holes with left to right configuration. |
| M248280064011 | The Viper distal volar radius plate consists of four holes with left to right configuration. |
| M248271427301 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427201 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427181 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427161 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427121 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M268VIPERSET0 | The VIPERSET consists of a distal volar radius plate with the option of either a 4-hole or 6-hol |
Trademark Results [Viper]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIPER 98774058 not registered Live/Pending |
Proven Winners North America LLC 2024-09-27 |
 VIPER 98576205 not registered Live/Pending |
Total Finishing Solutions, LLC. 2024-05-30 |
 VIPER 98543368 not registered Live/Pending |
Greg Lucero 2024-05-10 |
 VIPER 98512687 not registered Live/Pending |
S&B Technical Products, Inc. 2024-04-22 |
 VIPER 98484950 not registered Live/Pending |
VM Products, Inc. 2024-04-04 |
 VIPER 98484922 not registered Live/Pending |
VM Products, Inc. 2024-04-04 |
 VIPER 98484879 not registered Live/Pending |
Cala Industries, Inc. 2024-04-04 |
 VIPER 98468050 not registered Live/Pending |
PATRIOT MEMORY, INC. 2024-03-26 |
 VIPER 98385826 not registered Live/Pending |
Gaatu Inc. 2024-02-01 |
 VIPER 98310533 not registered Live/Pending |
RFA Brands, LLC d/b/a My Charge 2023-12-12 |
 VIPER 98299117 not registered Live/Pending |
Delta T, LLC 2023-12-05 |
 VIPER 98192919 not registered Live/Pending |
Gaatu Inc. 2023-09-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.