PERLA ® TL TLF-PS 60 25-S
GUDID 07640305165641
POLYAXIAL SCREW Ø6 L25
SpineArt SA
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 07640305165641 |
| NIH Device Record Key | ce1c0b76-b36b-49c6-a9f0-2c612e3c34c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERLA ® TL |
| Version Model Number | TLF-PS 60 25-S |
| Catalog Number | TLF-PS 60 25-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 | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640305165641 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193396
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 | 2020-04-23 |
| Device Publish Date | 2020-02-17 |
On-Brand Devices [PERLA ® TL]
| 07640185346710 | PREBENT ROD TITANIUM Ø5.5 L90 |
| 07640185346703 | PREBENT ROD TITANIUM Ø5.5 L80 |
| 07640185346697 | PREBENT ROD TITANIUM Ø5.5 L70 |
| 07640185346680 | PREBENT ROD TITANIUM Ø5.5 L60 |
| 07640185346673 | PREBENT ROD TITANIUM Ø5.5 L55 |
| 07640185346666 | PREBENT ROD TITANIUM Ø5.5 L50 |
| 07640185346659 | PREBENT ROD TITANIUM Ø5.5 L45 |
| 07640185346642 | PREBENT ROD TITANIUM Ø5.5 L40 |
| 07640185346635 | PREBENT ROD TITANIUM Ø5.5 L35 |
| 07640185346628 | PREBENT ROD TITANIUM Ø5.5 L30 |
| 07640185348738 | PREBENT ROD TITANIUM Ø5.5 L110 |
| 07640185346727 | PREBENT ROD TITANIUM Ø5.5 L100 |
| 07640185348998 | ROD CONNECTOR AXIAL OPEN/CLOSE |
| 07640185348790 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L110 |
| 07640185348783 | PREBENT ROD TITANIUM Ø6 L130 |
| 07640185348776 | PREBENT ROD TITANIUM Ø6 L110 |
| 07640185348769 | STRAIGHT ROD HEXA TITANIUM Ø6 L110 |
| 07640185348752 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø5.5 L110 |
| 07640185348745 | PREBENT ROD TITANIUM Ø5.5 L130 |
| 07640185348721 | STRAIGHT ROD HEXA TITANIUM Ø5.5 L110 |
| 07640185347298 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L550 |
| 07640185347281 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L500 |
| 07640185347274 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L350 |
| 07640185347267 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L280 |
| 07640185347250 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L240 |
| 07640185347243 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L200 |
| 07640185347236 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L180 |
| 07640185347229 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L160 |
| 07640185347212 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L140 |
| 07640185347205 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L120 |
| 07640185347199 | STRAIGHT ROD HEXA COBALT CHROMIUM Ø6 L100 |
| 07640185347182 | PREBENT ROD TITANIUM Ø6 L120 |
| 07640185347175 | PREBENT ROD TITANIUM Ø6 L100 |
| 07640185347168 | PREBENT ROD TITANIUM Ø6 L90 |
| 07640185347151 | PREBENT ROD TITANIUM Ø6 L80 |
| 07640185347144 | PREBENT ROD TITANIUM Ø6 L70 |
| 07640185347137 | PREBENT ROD TITANIUM Ø6 L60 |
| 07640185347120 | PREBENT ROD TITANIUM Ø6 L55 |
| 07640185347113 | PREBENT ROD TITANIUM Ø6 L50 |
| 07640185347106 | PREBENT ROD TITANIUM Ø6 L45 |
| 07640185347090 | PREBENT ROD TITANIUM Ø6 L40 |
| 07640185347083 | PREBENT ROD TITANIUM Ø6 L35 |
| 07640185347076 | PREBENT ROD TITANIUM Ø6 L30 |
| 07640185347069 | STRAIGHT ROD HEXA TITANIUM Ø6 L550 |
| 07640185347052 | STRAIGHT ROD HEXA TITANIUM Ø6 L500 |
| 07640185347045 | STRAIGHT ROD HEXA TITANIUM Ø6 L350 |
| 07640185347038 | STRAIGHT ROD HEXA TITANIUM Ø6 L280 |
| 07640185347021 | STRAIGHT ROD HEXA TITANIUM Ø6 L240 |
| 07640185347007 | STRAIGHT ROD HEXA TITANIUM Ø6 L200 |
| 07640185346994 | STRAIGHT ROD HEXA TITANIUM Ø6 L180 |
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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