PERLA ® CPF-PS 45 36-S
GUDID 07640185341616
POLYAXIAL SCREW
SpineArt SA
Spinal bone screw, non-bioabsorbable| Primary Device ID | 07640185341616 |
| NIH Device Record Key | 9693d0f4-3d71-4b37-8f3c-732e4d3f30ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERLA ® |
| Version Model Number | CPF-PS 45 36-S |
| Catalog Number | CPF-PS 45 36-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
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 36 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640185341616 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190071
FDA Product Code
| KWP | Appliance, Fixation, Spinal Interlaminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2019-03-01 |
On-Brand Devices [PERLA ®]
| 07640178981782 | Pedicle Probe Curved |
| 07640178981775 | Driver T20 |
| 07640178981768 | Screwdriver T20 |
| 07640178981751 | Rod template L100 |
| 07640178977884 | SMOOTH SHANK SCREW |
| 07640178977877 | SMOOTH SHANK SCREW |
| 07640178977860 | SMOOTH SHANK SCREW |
| 07640178977853 | SMOOTH SHANK SCREW |
| 07640178977846 | LATERAL CONNECTOR / L |
| 07640178977839 | LATERAL CONNECTOR / S |
| 07640178977822 | RTR CROSS CONNECTOR |
| 07640178977815 | RTR CROSS CONNECTOR |
| 07640178977808 | RTR CROSS CONNECTOR |
| 07640178977792 | RTR CROSS CONNECTOR |
| 07640178977785 | RTR CROSS CONNECTOR |
| 07640178977778 | HTH CROSS CONNECTOR |
| 07640178977761 | HTH CROSS CONNECTOR |
| 07640178977754 | HTH CROSS CONNECTOR |
| 07640178977747 | HTH CROSS CONNECTOR |
| 07640178977730 | HTH CROSS CONNECTOR |
| 07640178977723 | HTH CROSS CONNECTOR |
| 07640178977716 | PARALLEL CONNECTOR 3O-5C |
| 07640178977709 | PARALLEL CONNECTOR 3C-5O |
| 07640178977693 | PARALLEL CONNECTOR 3C-3C |
| 07640178977686 | PARALLEL CONNECTOR 3O-3C |
| 07640178977662 | AXIAL CONNECTOR 3O-5C |
| 07640178977655 | HOOK STRAIGHT / L |
| 07640178977648 | HOOK STRAIGHT / S |
| 07640178977631 | HOOK OFFSET LEFT / L |
| 07640178977624 | HOOK OFFSET RIGHT / L |
| 07640178977617 | HOOK OFFSET LEFT / S |
| 07640178977600 | HOOK OFFSET RIGHT / S |
| 07640178977594 | TRANSITION ROD COBALT CHROMIUM |
| 07640178977587 | TRANSITION ROD COBALT CHROMIUM |
| 07640178977570 | TRANSITION ROD TITANIUM |
| 07640178977563 | TRANSITION ROD TITANIUM |
| 07640178977556 | PREBENT ROD COBALT CHROMIUM |
| 07640178977549 | PREBENT ROD COBALT CHROMIUM |
| 07640178977532 | PREBENT ROD COBALT CHROMIUM |
| 07640178977525 | PREBENT ROD COBALT CHROMIUM |
| 07640178977518 | PREBENT ROD COBALT CHROMIUM |
| 07640178977501 | PREBENT ROD COBALT CHROMIUM |
| 07640178977495 | PREBENT ROD COBALT CHROMIUM |
| 07640178977488 | PREBENT ROD COBALT CHROMIUM |
| 07640178977471 | PREBENT ROD COBALT CHROMIUM |
| 07640178977464 | PREBENT ROD COBALT CHROMIUM |
| 07640178977457 | PREBENT ROD COBALT CHROMIUM |
| 07640178977440 | STRAIGHT ROD COBALT CHROMIUM |
| 07640178977433 | CPF-SR C2 40-S |
| 07640178977426 | STRAIGHT ROD COBALT CHROMIUM |
Trademark Results [PERLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERLA 98533824 not registered Live/Pending |
El Carmen, Inc. 2024-05-03 |
 PERLA 97858477 not registered Live/Pending |
2904802 Canada Inc 2023-03-27 |
 PERLA 97847591 not registered Live/Pending |
El Carmen, Inc. 2023-03-20 |
 PERLA 97748960 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
 PERLA 97748932 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
 PERLA 97748920 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
 PERLA 97748900 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
 PERLA 97748766 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
 PERLA 97728735 not registered Live/Pending |
Acosta, Perla 2022-12-22 |
PERLA 97728735 not registered Live/Pending |
Acosta, Perla 2022-12-22 |
 PERLA 97599549 not registered Live/Pending |
Perla on Broadway Homeowners Association 2022-09-20 |
 PERLA 97059035 not registered Live/Pending |
El Carmen, Inc. 2021-10-04 |
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