Malibu™ 12-1035
GUDID 10889981029944
PRECONTOURED ROD, 5.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981029944 |
| NIH Device Record Key | 9635bd2d-b16a-41c8-b472-ca6cfe2390b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Malibu™ |
| Version Model Number | 12-1035 |
| Catalog Number | 12-1035 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981029944 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061342
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
[10889981029944]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [Malibu™]
| 10889981030834 | PRECONTOURED ESS PLUS ROD, 5.5 x 600 mm |
| 10889981030827 | PRECONTOURED ESS PLUS ROD, 5.5 x 500 mm |
| 10889981030810 | PRECONTOURED ESS PLUS ROD, 5.5 x 400 mm |
| 10889981030803 | PRECONTOURED ESS PLUS ROD, 5.5 x 300 mm |
| 10889981030797 | ESS PLUS ROD, 5.5 x 450 mm |
| 10889981030162 | MALIBU MONO/HOOK CAP, 5.5/6.35 |
| 10889981030155 | PRECONTOURED ESS ROD, 5.5 x 600 mm |
| 10889981030148 | PRECONTOURED ESS ROD, 5.5 x 500 mm |
| 10889981030131 | PRECONTOURED ESS ROD, 5.5 x 400 mm |
| 10889981030124 | PRECONTOURED ESS ROD, 5.5 x 350 mm |
| 10889981030117 | PRECONTOURED ESS ROD, 5.5 x 300 mm |
| 10889981030100 | PRECONTOURED ESS ROD, 5.5 x 90 mm |
| 10889981030094 | PRECONTOURED ESS ROD, 5.5 x 80 mm |
| 10889981030087 | ESS ROD, 5.5 x 600 mm |
| 10889981030070 | ESS ROD, 5.5 x 450 mm |
| 10889981030063 | ESS ROD, 5.5 x 250 mm |
| 10889981030056 | ESS ROD, 5.5 x 100 mm |
| 10889981030049 | PRECONTOURED ROD, 5.5 x 75mm |
| 10889981030032 | PRECONTOURED ROD, 5.5 x 65mm |
| 10889981030025 | PRECONTOURED ROD, 5.5 x 55mm |
| 10889981030018 | PRECONTOURED ROD, 5.5 x 45mm |
| 10889981030001 | ROD CONNECTOR, 5.5 x 5.5 |
| 10889981029999 | PRECONTOURED ROD, 5.5 x 80mm |
| 10889981029982 | PRECONTOURED ROD, 5.5 x 70mm |
| 10889981029975 | PRECONTOURED ROD, 5.5 x 60mm |
| 10889981029968 | PRECONTOURED ROD, 5.5 x 50mm |
| 10889981029951 | PRECONTOURED ROD, 5.5 x 40mm |
| 10889981029944 | PRECONTOURED ROD, 5.5 x 35mm |
| 10889981029937 | PRECONTOURED ROD, 5.5 x 30mm |
| 10889981029920 | SCREW SPACER 7.0-7.5mmDIA X 5.0mm |
| 10889981029913 | SCREW SPACER 6.0-6.5mmDIA X 2.5mm |
| 10889981029906 | SCREW SPACER 4.5-8.5MM X 5.0MM |
| 10889981029890 | CLOSED LATERAL CONNECTOR, 6.35 X 60MM |
| 10889981029883 | ESS SUBLAMINAR WIRE, 1.2 mm |
| 10889981029876 | PRECONTOURED TI ROD, 5.5 X 500mm |
| 10889981029869 | PRECONTOURED TI ROD, 5.5 X 400mm |
| 10889981029852 | PRECONTOURED TI ROD, 5.5 X 300mm |
| 10889981029845 | CLOSED LATERAL CONNECTOR, 6.35 X 45MM |
| 10889981029838 | CLOSED LATERAL CONNECTOR, 6.35 X 30MM |
| 10889981029821 | CLOSED LATERAL CONNECTOR, 5.5/6.35 X 60MM |
| 10889981029814 | CLOSED LATERAL CONNECTOR, 5.5 X 60MM |
| 10889981029807 | CLOSED LATERAL CONNECTOR, 5.5 X 45MM |
| 10889981029791 | CLOSED LATERAL CONNECTOR, 5.5 X 30MM |
| 10889981029784 | PRECONTOURED ROD, 5.5 x 130mm |
| 10889981029777 | PRECONTOURED ROD, 5.5 x 120mm |
| 10889981029760 | PRECONTOURED ROD, 5.5 x 110mm |
| 10889981029753 | PRECONTOURED ROD, 5.5 x 100mm |
| 10889981029746 | PRECONTOURED ROD, 5.5 x 90mm |
| 10889981029739 | CLOSED LATERAL CONNECTOR, 5.5/6.35 X 30MM |
| 10889981029722 | ROD CONNECTOR, 5.5/6.35 |
Trademark Results [Malibu]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MALIBU 98664199 not registered Live/Pending |
The Absolut Company Aktiebolag 2024-07-24 |
 MALIBU 98587713 not registered Live/Pending |
The Absolut Company Aktiebolag 2024-06-06 |
 MALIBU 98349362 not registered Live/Pending |
INNOVA VASCULAR, INC. 2024-01-09 |
 MALIBU 98197710 not registered Live/Pending |
Goodsmann Group LLC 2023-09-26 |
 MALIBU 97901291 not registered Live/Pending |
Albaugh, LLC 2023-04-21 |
 MALIBU 97742878 not registered Live/Pending |
The Absolut Company Aktiebolag 2023-01-05 |
 MALIBU 97733200 not registered Live/Pending |
The Absolut Company Aktiebolag 2022-12-27 |
 MALIBU 97640098 not registered Live/Pending |
Commonwealth Brands, Inc. 2022-10-20 |
 MALIBU 97518996 not registered Live/Pending |
The Absolut Company Aktiebolag 2022-07-25 |
 MALIBU 97518517 not registered Live/Pending |
J2F Management LLC 2022-07-25 |
 MALIBU 97208202 not registered Live/Pending |
Stork Craft Manufacturing (USA) Inc. 2022-01-07 |
 MALIBU 97052106 not registered Live/Pending |
THE ABSOLUT COMPANY AKTIEBOLAG 2021-09-29 |
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