ENDOSKELETON® TL Hyperlordotic Sterile Barrier System 7300-6535-S
GUDID 00191375036791
Bone Screw, 6.5mm x 35mm
TITAN SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00191375036791 |
| NIH Device Record Key | cb544e03-12e0-4400-be15-cc736596d83d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TL Hyperlordotic Sterile Barrier System |
| Version Model Number | 7300-6535-S |
| Catalog Number | 7300-6535-S |
| Company DUNS | 623316978 |
| Company Name | TITAN SPINE, LLC |
| 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 | true |
| Expiration Date | true |
| 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
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
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| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
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| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
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| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375036791 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191581
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-24 |
| Device Publish Date | 2020-08-15 |
On-Brand Devices [ENDOSKELETON® TL Hyperlordotic Sterile Barrier System]
| 00191375036845 | Bone Screw, 6.5mm x 60mm |
| 00191375036838 | Bone Screw, 6.5mm x 55mm |
| 00191375036821 | Bone Screw, 6.5mm x 50mm |
| 00191375036814 | Bone Screw, 6.5mm x 45mm |
| 00191375036807 | Bone Screw, 6.5mm x 40mm |
| 00191375036791 | Bone Screw, 6.5mm x 35mm |
| 00191375036784 | Bone Screw, 6.5mm x 30mm |
| 00191375036777 | Bone Screw, 6.5mm x 25mm |
| 00191375036760 | Bone Screw, 5.5mm x 60mm |
| 00191375036753 | Bone Screw, 5.5mm x 55mm |
| 00191375036746 | Bone Screw, 5.5mm x 50mm |
| 00191375036739 | Bone Screw, 5.5mm x 45mm |
| 00191375036722 | Bone Screw, 5.5mm x 40mm |
| 00191375036715 | Bone Screw, 5.5mm x 35mm |
| 00191375036708 | Bone Screw, 5.5mm x 30mm |
| 00191375036692 | Bone Screw, 5.5mm x 25mm |
| 00191375031970 | Lateral Plate, 2 Screw Hole, 18mm |
| 00191375031963 | Lateral Plate, 2 Screw Hole, 16mm |
| 00191375031956 | Lateral Plate, 2 Screw Hole, 14mm |
| 00191375031949 | Lateral Plate, 1 Screw Hole, 18mm |
| 00191375031932 | Lateral Plate, 1 Screw Hole, 16mm |
| 00191375031925 | Lateral Plate, 1 Screw Hole, 14mm |
Trademark Results [ENDOSKELETON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSKELETON 76550301 3174488 Live/Registered |
TITAN SPINE, INC. 2003-09-22 |
 ENDOSKELETON 74130100 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1991-01-14 |
 ENDOSKELETON 74130099 1719530 Live/Registered |
STUDIOCANAL, S.A. 1991-01-14 |
 ENDOSKELETON 74124953 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
 ENDOSKELETON 74124952 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
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