RIALTO™ SI FUSION SYSTEM
GUDID 00643169571846
DEVICE 74200001250 THREADED 12X50
MEDTRONIC SOFAMOR DANEK, INC.
Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)| Primary Device ID | 00643169571846 |
| NIH Device Record Key | ed1eb79c-9d71-4641-b1b4-986e3d7e76e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIALTO™ SI FUSION SYSTEM |
| Version Model Number | 74200001250 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169571846 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161210
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-13 |
On-Brand Devices [RIALTO™ SI FUSION SYSTEM]
| 00643169572577 | TAP 7426003 RIALTO 12MM |
| 00643169572560 | REAMER 7426002 RIALTO 8.6MM |
| 00643169571860 | DEVICE 74200001260 THREADED 12X60 |
| 00643169571846 | DEVICE 74200001250 THREADED 12X50 |
| 00643169571822 | DEVICE 74200001240 THREADED 12X40 |
| 00643169571815 | REAMER NAV7426002 PILOT RIALTO |
| 00643169571808 | DRIVER NAV7426001 SCREW RIALTO |
| 00643169571792 | TAP NAV7426000 SELF DRILLING RIALTO |
| 00643169572546 | DRIVER 7426000 RIALTO ADJUSTMENT |
| 00643169273924 | SCREW 9000240 SI TI CANN 12X40 |
| 00643169273900 | SCREW 9000245 SI TI CANN 12X45 |
| 00643169273887 | SCREW 9000250 SI TI CANN 12X50 |
| 00643169273863 | SCREW 9000255 SI TI CANN 12X55 |
| 00643169273849 | SCREW 9000260 SI TI CANN 12X60 |
| 00643169572584 | DRIVER 7426004 RIALTO T27 THREADED |
Trademark Results [RIALTO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RIALTO 98004528 not registered Live/Pending |
Cerámica Rialto S.A 2023-05-19 |
 RIALTO 97746543 not registered Live/Pending |
ST Engineering Aethon, Inc. 2023-01-09 |
 RIALTO 97565809 not registered Live/Pending |
Unicorn Jungle 2022-08-25 |
 RIALTO 97565775 not registered Live/Pending |
Unicorn Jungle 2022-08-25 |
 RIALTO 97285492 not registered Live/Pending |
Summerset Technologies LLC 2022-02-25 |
 RIALTO 97285486 not registered Live/Pending |
Summerset Technologies LLC 2022-02-25 |
 RIALTO 97119586 not registered Live/Pending |
ProQuest LLC 2021-11-11 |
 RIALTO 87874542 not registered Dead/Abandoned |
Friedland, Fabian 2018-04-12 |
 RIALTO 87785889 not registered Live/Pending |
CONNORS, FONG AND MANCUSO, INC. 2018-02-06 |
 RIALTO 87776609 not registered Live/Pending |
Rialto Trading Holdings LLC 2018-01-30 |
 RIALTO 87776545 5791507 Live/Registered |
Rialto Trading Holdings LLC 2018-01-30 |
 RIALTO 87680556 5597286 Live/Registered |
Balanced Body, Inc. 2017-11-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.