FacetBRIDGE FS5530W
GUDID 03662663029636
LDR Spine Usa, Inc.
Trans-facet-screw internal spinal fixation system, sterile| Primary Device ID | 03662663029636 |
| NIH Device Record Key | d47de78e-6320-41fe-83b8-3d11672cdc35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FacetBRIDGE |
| Version Model Number | FS5530W |
| Catalog Number | FS5530W |
| Company DUNS | 615789729 |
| Company Name | LDR Spine Usa, Inc. |
| 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 | false |
| 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 | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663029636 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161798
FDA Product Code
| MRW | System, Facet Screw Spinal Device |
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 | 2022-03-10 |
| Device Publish Date | 2018-11-01 |
On-Brand Devices [FacetBRIDGE]
| 03662663026208 | FS9023R |
| 03662663026192 | FS9022R |
| 03662663023801 | FS9041R |
| 03662663023788 | FS9031R |
| 03662663023771 | FS9030R |
| 03662663023764 | FS9021R |
| 03662663023757 | FS9020R |
| 03662663026239 | FS990A |
| 03662663043014 | ROI-A |
| 03662663029681 | FS5555W |
| 03662663029674 | FS5550W |
| 03662663029667 | FS5545W |
| 03662663029650 | FS5540W |
| 03662663029643 | FS5535W |
| 03662663029636 | FS5530W |
| 03662663029629 | FS5525W |
| 03662663029612 | FS5550W |
| 03662663029605 | FS5517W |
| 03662663029599 | FS5515W |
| 03662663029582 | FS4555W |
| 03662663029575 | FS4550W |
| 03662663029568 | FS4545W |
| 03662663029551 | FS4540W |
| 03662663029544 | FS4535W |
| 03662663029537 | FS4530W |
| 03662663029520 | FS4525W |
| 03662663029513 | FS4520W |
| 03662663029506 | FS4517W |
| 03662663029490 | FS4515W |
| 03662663026505 | FacetBRIDGE screw D5.5mm L55mm |
| 03662663026499 | FacetBRIDGE screw D5.5mm L50mm |
| 03662663026482 | FacetBRIDGE screw D5.5mm L45mm |
| 03662663026475 | FacetBRIDGE screw D5.5mm L40mm |
| 03662663026468 | FacetBRIDGE screw D5.5mm L35mm |
| 03662663026451 | FacetBRIDGE screw D5.5mm L30mm |
| 03662663026444 | FacetBRIDGE screw D5.5mm L25mm |
| 03662663026437 | FacetBRIDGE screw D5.5mm L20mm |
| 03662663026420 | FacetBRIDGE screw D5.5mm L17.5mm |
| 03662663026413 | FacetBRIDGE screw D5.5mm L15mm |
| 03662663026406 | FacetBRIDGE screw D4.5mm L55mm |
| 03662663026390 | FacetBRIDGE screw D4.5mm L50mm |
| 03662663026383 | FacetBRIDGE screw D4.5mm L45mm |
| 03662663026376 | FacetBRIDGE screw D4.5mm L40mm |
| 03662663026369 | FacetBRIDGE screw D4.5mm L35mm |
| 03662663026352 | FacetBRIDGE screw D4.5mm L30mm |
| 03662663026345 | FacetBRIDGE screw D4.5mm L25mm |
| 03662663026338 | FacetBRIDGE screw D4.5mm L20mm |
| 03662663026321 | FacetBRIDGE screw D4.5mm L17.5mm |
| 03662663026314 | FacetBRIDGE screw D4.5mm L15mm |
| 03662663026222 | FS9053R |
Trademark Results [FacetBRIDGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FACETBRIDGE 86563322 5074083 Live/Registered |
LDR Medical, S.A.S. 2015-03-13 |
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