TRYPTIK®2 C-Plate Anterior Cervical Plate System TRY-PS 45 20-S
GUDID 07640178985087
SELF-TAPPING SCREW, POLYAXIAL, Ø4.5 L20
SpineArt SA
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 07640178985087 |
| NIH Device Record Key | 46ac24f5-6a72-4c8b-a593-836af563e8db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRYPTIK®2 C-Plate Anterior Cervical Plate System |
| Version Model Number | TRY-PS 45 20-S |
| Catalog Number | TRY-PS 45 20-S |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| 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 | 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 |
Device Dimensions
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640178985087 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153042
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2017-08-31 |
On-Brand Devices [TRYPTIK®2 C-Plate Anterior Cervical Plate System]
| 07640178974982 | 2 LEVEL PLATE LENGTH 52 MM |
| 07640178974975 | 2 LEVEL PLATE LENGTH 49 MM |
| 07640178974968 | 2 LEVEL PLATE LENGTH 46 MM |
| 07640178974951 | 2 LEVEL PLATE LENGTH 43 MM |
| 07640178974944 | 2 LEVEL PLATE LENGTH 40 MM |
| 07640178974937 | 2 LEVEL PLATE LENGTH 38 MM |
| 07640178974920 | 2 LEVEL PLATE LENGTH 36 MM |
| 07640178974913 | 2 LEVEL PLATE LENGTH 34 MM |
| 07640178974906 | 2 LEVEL PLATE LENGTH 32 MM |
| 07640178974890 | 4 LEVEL PLATE LENGTH 88 MM |
| 07640178974883 | 4 LEVEL PLATE LENGTH 84 MM |
| 07640178974876 | 4 LEVEL PLATE LENGTH 80 MM |
| 07640178974869 | 4 LEVEL PLATE LENGTH 76 MM |
| 07640178974852 | 4 LEVEL PLATE LENGTH 92 MM |
| 07640151108526 | SELF-DRILLING SCREW, POLYAXIAL, Ø4.5 L18 |
| 07640151108519 | SELF-DRILLING SCREW, POLYAXIAL, Ø4.5 L16 |
| 07640151108502 | SELF-DRILLING SCREW, POLYAXIAL, Ø4.5 L14 |
| 07640151108496 | SELF-DRILLING SCREW, POLYAXIAL, Ø4.5 L12 |
| 07640151108489 | SELF-DRILLING SCREW, POLYAXIAL, Ø4 L18 |
| 07640151108472 | SELF-DRILLING SCREW, POLYAXIAL, Ø4 L16 |
| 07640151108465 | SELF-DRILLING SCREW, POLYAXIAL, Ø4 L14 |
| 07640151108458 | SELF-DRILLING SCREW, POLYAXIAL, Ø4 L12 |
| 07640151108441 | SELF-DRILLING SCREW, POLYRIGID, Ø4.5 X L18 |
| 07640151108434 | SELF-DRILLING SCREW, POLYRIGID, Ø4.5 X L16 |
| 07640151108427 | SELF-DRILLING SCREW, POLYRIGID, Ø4.5 X L14 |
| 07640151108410 | SELF-DRILLING SCREW, POLYRIGID, Ø4.5 X L12 |
| 07640151108403 | SELF-DRILLING SCREW, POLYRIGID, Ø4.0 X L18 |
| 07640151108397 | SELF-DRILLING SCREW, POLYRIGID, Ø4.0 X L16 |
| 07640151108625 | SELF-DRILLING SCREW, POLYRIGID, Ø4.0 X L14 |
| 07640151108373 | SELF-DRILLING SCREW, POLYRIGID, Ø4.0 X L12 |
| 07640151108366 | SELF-TAPPING SCREW, POLYAXIAL, Ø4.5 L18 |
| 07640151108359 | SELF-TAPPING SCREW, POLYAXIAL, Ø4.5 L16 |
| 07640151108342 | SELF-TAPPING SCREW, POLYAXIAL, Ø4.5 L14 |
| 07640151108335 | SELF-TAPPING SCREW, POLYAXIAL, Ø4.5 L12 |
| 07640151108328 | SELF-TAPPING SCREW, POLYAXIAL, Ø4 L18 |
| 07640151108311 | SELF-TAPPING SCREW, POLYAXIAL, Ø4 L16 |
| 07640151108304 | SELF-TAPPING SCREW, POLYAXIAL, Ø4 L14 |
| 07640151108298 | SELF-TAPPING SCREW, POLYAXIAL, Ø4 L12 |
| 07640151108281 | SELF-TAPPING SCREW, POLYRIGID, Ø4.5 X L18 |
| 07640151108274 | SELF-TAPPING SCREW, POLYRIGID, Ø4.5 X L16 |
| 07640151108267 | SELF-TAPPING SCREW, POLYRIGID, Ø4.5 X L14 |
| 07640151108250 | SELF-TAPPING SCREW, POLYRIGID, Ø4.5 X L12 |
| 07640151108564 | SELF-TAPPING SCREW, POLYRIGID, Ø4.0 X L18 |
| 07640151108557 | SELF-TAPPING SCREW, POLYRIGID, Ø4.0 X L16 |
| 07640151108540 | SELF-TAPPING SCREW, POLYRIGID, Ø4.0 X L14 |
| 07640151108533 | SELF-TAPPING SCREW, POLYRIGID, Ø4.0 X L12 |
| 07640151108205 | 3 LEVEL PLATE LENGTH 72 MM |
| 07640151108199 | 3 LEVEL PLATE LENGTH 68 MM |
| 07640151108182 | 3 LEVEL PLATE LENGTH 64 MM |
| 07640151108175 | 3 LEVEL PLATE LENGTH 61 MM |
Trademark Results [TRYPTIK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRYPTIK 79053319 3619560 Live/Registered |
SPINEART S.A. 2008-04-25 |
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