Primary Device ID | 10840642111279 |
NIH Device Record Key | 5dc789a2-413e-41d1-9d92-18305b044277 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leva® Anterior Expandable Spacer System |
Version Model Number | 10-0316 |
Catalog Number | 10-0316 |
Company DUNS | 067789763 |
Company Name | Spine Wave, 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642111279 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-04-30 |
10840642111293 | Large/Extra Large Removal Instrument |
10840642111286 | Small/Medium Removal Instrument |
10840642111279 | Large/Extra Large Inserter Tip |
10840642111262 | Small/Medium Inserter Tip |
10840642111255 | Inserter Handle |
10840642109351 | Spacer, 38 mm (W) x 30 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109344 | Spacer, 38 mm (W) x 30 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109337 | Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109320 | Spacer, 26 mm (W) x 26 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109313 | Spacer, 26 mm (W) x 26 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109306 | Spacer, 26 mm (W) x 26 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109290 | Spacer, 34 mm (W) x 30 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109283 | Spacer, 34 mm (W) x 30 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109276 | Spacer, 34 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109269 | Spacer, 30 mm (W) x 28 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109252 | Spacer, 30 mm (W) x 28 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109245 | Spacer, 30 mm (W) x 28 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion |
10840642109238 | Spacer, 38 mm (W) x 30 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109221 | Spacer, 38 mm (W) x 30 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109214 | Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109207 | Spacer, 26 mm (W) x 26 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109191 | Spacer, 26 mm (W) x 26 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109184 | Spacer, 26 mm (W) x 26 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109177 | Spacer, 34 mm (W) x 30 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109160 | Spacer, 34 mm (W) x 30 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109153 | Spacer, 34 mm (W) x 30 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109146 | Spacer, 30 mm (W) x 28 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109139 | Spacer, 30 mm (W) x 28 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion |
10840642109122 | Spacer, 30 mm (W) x 28 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LEVA 97898990 not registered Live/Pending |
Axena Health, Inc. 2023-04-20 |
![]() LEVA 97868863 not registered Live/Pending |
Makabe, Tyler T 2023-04-01 |
![]() LEVA 97278880 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 97278844 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 97278819 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 90588009 not registered Live/Pending |
Fawcett, Katherine A 2021-03-18 |
![]() LEVA 87642018 not registered Live/Pending |
LevaData, Inc. 2017-10-11 |
![]() LEVA 87469324 5400130 Live/Registered |
Vinex Slavyantsi AD 2017-05-31 |
![]() LEVA 87469324 5400130 Live/Registered |
Giertz Vinimport AB 2017-05-31 |
![]() LEVA 86136186 4841918 Live/Registered |
Spine Wave, Inc. 2013-12-05 |
![]() LEVA 86054368 5036873 Live/Registered |
Remendium Labs LLC 2013-09-03 |
![]() LEVA 86054360 5036872 Live/Registered |
Remendium Labs LLC 2013-09-03 |