MD-Vue™ Lateral Discectomy System 60-BK-7004

GUDID 00840019967365

Implant Caddy - 18mm x 15° w/ 18mm H Kit

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00840019967365
NIH Device Record Keyac31ff07-b79a-450a-a11e-3510c34252f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD-Vue™ Lateral Discectomy System
Version Model Number60-BK-7004
Catalog Number60-BK-7004
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019967365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


[00840019967365]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [MD-Vue™ Lateral Discectomy System]

00840019966924Angled Trial 18 X 08mm 0°
00840019967310Trial 24 x 18 mm 15°
00840019967303Angled Trial 24 X 16mm 0°
00840019967297Trial 24 x 16 mm 15°
00840019967280Trial 24 x 16 mm 0°
00840019967273Trial 24 x 16 mm 7°
00840019967266Angled Trial 24 X 14mm 0°
00840019967259Trial 24 x 14 mm 15°
00840019967242Trial 24 x 14 mm 0°
00840019967235Trial 24 x 14 mm 7°
00840019967228Angled Trial 24 X 12mm 0°
00840019967211Trial 24 x 12 mm 15°
00840019967204Trial 24 x 12 mm 0°
00840019967198Trial 24 x 12 mm 7°
00840019967181Angled Trial 24 X 10mm 0°
00840019967174Trial 24 x 10 mm 15°
00840019967167Trial 24 x 10 mm 0°
00840019967150Trial 24 x 10 mm 7°
00840019967143Angled Trial 24 X 08mm 0°
00840019967136Trial 24 x 08 mm 0°
00840019967129Trial 24 x 08 mm 7°
00840019967112Trial 22 x 18 mm 15°
00840019967105Angled Trial 22 X 16mm 0°
00840019967099Trial 22 x 16 mm 15°
00840019967082Angled Trial 22 X 14mm 0°
00840019967075Trial 22 x 14 mm 15°
00840019967068Angled Trial 22 X 12mm 0°
00840019967051Trial 22 x 12 mm 15°
00840019967044Angled Trial 22 X 10mm 0°
00840019967037Trial 22 x 10 mm 15°
00840019967020Angled Trial 22 X 08mm 0°
00840019967013Trial 18 x 18 mm 15°
00840019967006Angled Trial 18 X 16mm 0°
00840019966993Trial 18 x 16 mm 15°
00840019966986Angled Trial 18 X 14mm 0°
00840019966979Trial 18 x 14 mm 15°
00840019966962Angled Trial 18 X 12mm 0°
00840019966955Trial 18 x 12 mm 15°
00840019966948Angled Trial 18 X 10mm 0°
00840019966931Trial 18 x 10 mm 15°
00840019967334Implant Caddy - 24mm x 7° Kit
00840019967327Implant Caddy - 24mm x 7° (Empty)
0084001996743315° Implant Kit - 18mm & 22mm Widths
00840019967426Implant Caddy - 24mm x 15° w/ 18mm H Kit
00840019967419Implant Caddy - 24mm x 15° Kit
00840019967402Implant Caddy - 24mm x 15° (Empty)
00840019967396Implant Caddy - 22mm x 15° w/ 18mm H Kit
00840019967389Implant Caddy - 22mm x 15° Kit
00840019967372Implant Caddy - 22mm x 15° (Empty)
00840019967365Implant Caddy - 18mm x 15° w/ 18mm H Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.