Malibu 67-5535
GUDID 10889981007195
Uni-Planar Screw, 5.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981007195 |
| NIH Device Record Key | 31c26533-0b54-4f68-9542-78d010e9884b |
| Commercial Distribution Discontinuation | 2016-09-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Malibu |
| Version Model Number | 67-5535 |
| Catalog Number | 67-5535 |
| 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(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| 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 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 | 10889981007195 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051942
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
Moist Heat or Steam Sterilization
[10889981007195]
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]
| 10889981149482 | Auxiliary Tray, Inner Pin Mat |
| 10889981149475 | Auxiliary Tray, Pin Mat |
| 10889981149437 | Auxiliary Tray, Lid |
| 10889981149420 | Auxiliary Tray, Inner |
| 10889981149413 | Auxiliary Tray, Dual Level |
| 10889981149406 | Auxiliary Tray, Single Level |
| 10889981140250 | Offset hook, 5.5 x 11mm, right |
| 10889981140243 | Angled hook, 5.5 x9.0mm, right |
| 10889981140236 | Angled hook, 5.5 x 9.0 mm, left |
| 10889981140229 | Angled hook 5.5 x 10mm, left |
| 10889981134891 | Offset hook, 5.5 x 11mm, left |
| 10889981134884 | Angled hook, 5.5 x10mm, right |
| 10889981120320 | Cannulated Uni-Planar Dlta Screw DIA 5.5 x 55mm |
| 10889981119829 | ESS SUBLAMINAR WIRE, 1 mm |
| 10889981119652 | CLOSED LATERAL CONNECTOR, 5.5/6.35 X 45MM |
| 10889981119218 | Persuader Set Instrument |
| 10889981119126 | Mallibu 2 Instrument |
| 10889981083052 | Variable Speed Ratcheting Handle, 1/4in. Square |
| 10889981083045 | Variable Speed Ratcheting Handle, AO |
| 10889981082925 | Locking Malibu Driver Free Sleeve |
| 10889981082918 | Locking Malibu Sliding Lock |
| 10889981082901 | Locking Malibu Driver Sleeve |
| 10889981082895 | Locking Malibu Driver Shaft |
| 10889981082888 | Top Down Persuader, Guide |
| 10889981082871 | Top Down Persuader |
| 10889981082864 | Tab Counter Torque |
| 10889981082857 | Threaded Awl 7.0mm (For 7.5mm Screw) |
| 10889981082840 | Threaded Awl 6.0mm (For 6.5mm Screw) |
| 10889981082833 | Threaded Awl 5.0mm (For 5.5mm Screw) |
| 10889981082826 | Luer Lock Bone Probe |
| 10889981082802 | Rotating Counter Torque |
| 10889981082796 | Bone Probe Stylet |
| 10889981082789 | Luer Lock Bone Probe Cap |
| 10889981082772 | Bone Probe, T-Handle |
| 10889981082765 | Pedicle Marker Pin |
| 10889981082758 | Pedicle Marker Pin |
| 10889981082741 | Pedicle Marker |
| 10889981082734 | Sacral Iliac Probe Guide |
| 10889981082727 | Sacral Iliac Probe |
| 10889981082710 | DLTA Screw Driver Shaft, Short |
| 10889981082703 | DLTA Screw Driver Shaft |
| 10889981082697 | Hook Pusher |
| 10889981082680 | Malibu Hook Holder |
| 10889981082673 | Pedicle Finder |
| 10889981082666 | Lamina Finder |
| 10889981082635 | AO Pedicle Marker, Regular |
| 10889981082628 | Modular Torque Indicating T-Handle, 1/4 QC |
| 10889981082611 | Ratchet Handle, Internal |
| 10889981082604 | Ratchet Handle |
| 10889981082581 | Ratchet T-Handle Extended |
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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