ENDOSKELETON® TCS Sterile Barrier System 5302-3814-S
GUDID 00191375027591
Bone Screw, Locking, 3.8mm x 14mm
TITAN SPINE, LLC
Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00191375027591 |
| NIH Device Record Key | ab89808c-8dc4-40f3-8fbd-95a3339aec04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TCS Sterile Barrier System |
| Version Model Number | 5302-3814-S |
| Catalog Number | 5302-3814-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 | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 14 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375027591 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
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 | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
On-Brand Devices [ENDOSKELETON® TCS Sterile Barrier System]
| 00191375025696 | Interbody Fusion Device Parallel Large 12mm |
| 00191375025689 | Interbody Fusion Device Parallel Large 11mm |
| 00191375025672 | Interbody Fusion Device Parallel Large 10mm |
| 00191375025665 | Interbody Fusion Device Parallel Large 9mm |
| 00191375025658 | Interbody Fusion Device Parallel Large 8mm |
| 00191375025641 | Interbody Fusion Device Parallel Large 7mm |
| 00191375025634 | Interbody Fusion Device Parallel Large 6mm |
| 00191375025627 | Interbody Fusion Device Parallel Large 5mm |
| 00191375025610 | Interbody Fusion Device Parallel Medium 12mm |
| 00191375025603 | Interbody Fusion Device Parallel Medium 11mm |
| 00191375025597 | Interbody Fusion Device Parallel Medium 10mm |
| 00191375025580 | Interbody Fusion Device Parallel Medium 9mm |
| 00191375025573 | Interbody Fusion Device Parallel Medium 8mm |
| 00191375025566 | Interbody Fusion Device Parallel Medium 7mm |
| 00191375025559 | Interbody Fusion Device Parallel Medium 6mm |
| 00191375025542 | Interbody Fusion Device Parallel Medium 5mm |
| 00191375025535 | Interbody Fusion Device Parallel Small 12mm |
| 00191375025528 | Interbody Fusion Device Parallel Small 11mm |
| 00191375025511 | Interbody Fusion Device Parallel Small 10mm |
| 00191375025504 | Interbody Fusion Device Parallel Small 9mm |
| 00191375025498 | Interbody Fusion Device Parallel Small 8mm |
| 00191375025481 | Interbody Fusion Device Parallel Small 7mm |
| 00191375025474 | Interbody Fusion Device Parallel Small 6mm |
| 00191375025467 | Interbody Fusion Device Parallel Small 5mm |
| 00191375025450 | Interbody Fusion Device 6 Degree Large 12mm |
| 00191375025443 | Interbody Fusion Device 6 Degree Large 11mm |
| 00191375025436 | Interbody Fusion Device 6 Degree Large 10mm |
| 00191375025429 | Interbody Fusion Device 6 Degree Large 9mm |
| 00191375025412 | Interbody Fusion Device 6 Degree Large 8mm |
| 00191375025405 | Interbody Fusion Device 6 Degree Large 7mm |
| 00191375025399 | Interbody Fusion Device 6 Degree Large 6mm |
| 00191375025382 | Interbody Fusion Device 6 Degree Large 5mm |
| 00191375025375 | Interbody Fusion Device 6 Degree Medium 12mm |
| 00191375025368 | Interbody Fusion Device 6 Degree Medium 11mm |
| 00191375025351 | Interbody Fusion Device 6 Degree Medium 10mm |
| 00191375025344 | Interbody Fusion Device 6 Degree Medium 9mm |
| 00191375025337 | Interbody Fusion Device 6 Degree Medium 8mm |
| 00191375025320 | Interbody Fusion Device 6 Degree Medium 7mm |
| 00191375025313 | Interbody Fusion Device 6 Degree Medium 6mm |
| 00191375025306 | Interbody Fusion Device 6 Degree Medium 5mm |
| 00191375025290 | Interbody Fusion Device 6 Degree Small 12mm |
| 00191375025283 | Interbody Fusion Device 6 Degree Small 11mm |
| 00191375025276 | Interbody Fusion Device 6 Degree Small 10mm |
| 00191375025269 | Interbody Fusion Device 6 Degree Small 9mm |
| 00191375025252 | Interbody Fusion Device 6 Degree Small 8mm |
| 00191375025245 | Interbody Fusion Device 6 Degree Small 7mm |
| 00191375025238 | Interbody Fusion Device 6 Degree Small 6mm |
| 00191375025221 | Interbody Fusion Device 6 Degree Small 5mm |
| 00191375039976 | Locking Plate |
| 00191375027652 | Bone Screw, Locking, 3.8mm x 20mm |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.