| Primary Device ID | 10889981062514 |
| NIH Device Record Key | b67b4da0-474c-4368-a84f-d8745f171572 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zuma-L™ |
| Version Model Number | ZUML2IMP |
| Catalog Number | ZUML2IMP |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| 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 | |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981062514 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
[10889981062514]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2015-09-24 |
| 10889981062521 | Zuma-L 3 Implant |
| 10889981062514 | Zuma-L 2 Implant |
| 10889981060152 | Height Trial, 45mm x 18mm, 8° , L4-L5 |
| 10889981060145 | Height Trial, 45mm x 16mm, 8° , L4-L5 |
| 10889981060138 | Height Trial, 45mm x 14mm, 8° , L4-L5 |
| 10889981060121 | Height Trial, 45mm x 12mm, 8° , L4-L5 |
| 10889981060114 | Height Trial, 45mm x 10mm, 8° , L4-L5 |
| 10889981060107 | Height Trial, 45mm x 8mm, 8° , L4-L5 |
| 10889981060091 | Angled Starter Trial |
| 10889981060084 | Zuma-L Depth Trial, L4-L5 |
| 10889981060077 | Height Trial, 45mm x 18mm, 0 ° , L4-L5 |
| 10889981060060 | Height Trial, 45mm x 16mm, 0 ° , L4-L5 |
| 10889981060053 | Height Trial, 45mm x 14mm, 0 ° , L4-L5 |
| 10889981060046 | Height Trial, 45mm x 12mm, 0 ° , L4-L5 |
| 10889981060039 | Height Trial, 45mm x 10mm, 0 ° , L4-L5 |
| 10889981060022 | Height Trial, 45mm x 8mm, 0 ° , L4-L5 |
| 10889981060015 | Height Trial, 45mm x 18mm, 0 Deg |
| 10889981060008 | Height Trial, 45mm x 16mm, 0 Deg |
| 10889981059996 | Height Trial, 45mm x 14mm, 0 Deg |
| 10889981059989 | Height Trial, 45mm x 12mm, 0 Deg |
| 10889981059972 | Height Trial, 45mm x 10mm, 0 Deg |
| 10889981059965 | Height Trial, 45mm x 08mm, 0 Deg |
| 10889981059958 | Height Trial, 45 mm x 18 mm, 8° |
| 10889981059941 | Height Trial, 45 mm x 16 mm, 8° |
| 10889981059934 | Height Trial, 45 mm x 14 mm, 8° |
| 10889981059927 | Height Trial, 45 mm x 12 mm, 8° |
| 10889981059910 | Height Trial, 45 mm x 10 mm, 8° |
| 10889981059903 | Height Trial, 45 mm x 08 mm, 8° |
| 10889981059897 | Lateral Depth Trial, Small Hudson |
| 10889981059880 | Zuma-L Locking Cover, 18mm |
| 10889981059873 | Zuma-L Locking Cover, 16mm |
| 10889981059866 | Zuma-L Locking Cover, 14mm |
| 10889981059859 | Zuma-L Locking Cover, 12mm |
| 10889981059842 | Zuma-L Locking Cover, 10mm |
| 10889981059835 | Zuma-L Locking Cover, 8mm |
| 10889981059828 | Bone Screw, 6.5 x 65mm |
| 10889981059811 | Bone Screw, 6.5 x 60mm |
| 10889981059804 | Bone Screw, 6.5 x 55mm |
| 10889981059798 | Bone Screw, 6.5 x 50mm |
| 10889981059781 | Bone Screw, 6.5 x 45mm |
| 10889981059774 | Bone Screw, 6.5 x 40mm |
| 10889981059767 | Bone Screw, 6.5 x 35mm |
| 10889981059750 | Bone Screw, 6.5 x 30mm |
| 10889981059743 | Bone Screw, 6.5 x 25mm |
| 10889981059736 | Bone Screw, 5.5 x 65mm |
| 10889981059729 | Bone Screw, 5.5 x 60mm |
| 10889981059712 | Bone Screw, 5.5 x 55mm |
| 10889981059705 | Bone Screw, 5.5 x 50mm |
| 10889981059699 | Bone Screw, 5.5 x 45mm |
| 10889981059682 | Bone Screw, 5.5 x 40mm |