FixxSure® 5528-31
GUDID M7115528310
Innovasis, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | M7115528310 |
| NIH Device Record Key | c9c95209-de35-4833-b742-1e313ab8c916 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FixxSure® |
| Version Model Number | 5528-31 |
| Catalog Number | 5528-31 |
| Company DUNS | 156567492 |
| Company Name | Innovasis, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7115528310 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081331
FDA Product Code
| MNI | Orthosis, Spinal Pedicle Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
[M7115528310]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-04-15 |
On-Brand Devices [FixxSure®]
| M711LS4530 | SST, Radel |
| M7116046660 | 6046-66 |
| M7116036460 | 6036-46 |
| M7116031360 | 6031-36 |
| M7116028310 | 6028-31 |
| M71160280 | 6028 |
| M71160270 | 6027 |
| M71160260 | 6026 |
| M71160250 | 6025 |
| M71160240 | 6024 |
| M71160230 | 6023 |
| M7115547660 | 5547-66 |
| M7115546660 | 5546-66 |
| M7115537460 | 5537-46 |
| M7115536460 | 5536-46 |
| M7115531360 | 5531-36 |
| M7115528310 | 5528-31 |
| M71155280 | 5528 |
| M71155270 | 5527 |
| M71155260 | 5526 |
| M71155250 | 5525 |
| M71155240 | 5524 |
| M71155230 | 5523 |
Trademark Results [FixxSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIXXSURE 77858763 3923949 Live/Registered |
INNOVASIS, INC. 2009-10-27 |
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