Zeus-A

GUDID 00840916159139

ZEUS-A CAGE, 42W X 25DP X 12H,7 DEGREE (EXTRA WIDE 1 THREAD)

SPINAL ELEMENTS

Polymeric spinal interbody fusion cage
Primary Device ID00840916159139
NIH Device Record Keye88b857a-cd92-4dd1-b9af-a82dcf0ad13c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZeus-A
Version Model Number35-07422512
Company DUNS004022104
Company NameSPINAL ELEMENTS
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100840916159139 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


[00840916159139]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-22
Device Publish Date2020-04-14

On-Brand Devices [Zeus-A]

00840916159184ZEUS-A CAGE, 42W X 25DP X 22H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159177ZEUS-A CAGE, 42W X 25DP X 20H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159160ZEUS-A CAGE, 42W X 25DP X 18H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159153ZEUS-A CAGE, 42W X 25DP X 16H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159146ZEUS-A CAGE, 42W X 25DP X 14H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159139ZEUS-A CAGE, 42W X 25DP X 12H,7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159122ZEUS-A CAGE, 42W X 25DP X 10H, 7 DEGREE (EXTRA WIDE 1 THREAD)
00840916159115ZEUS-A CAGE, 42W X 25DP X 08H, 7 DEGREE
00840916158613ZEUS-A TAMP
00840916159924ANGLED ALIF TAMP
00840916159894ANTERIOR LUMBAR PLATE INSERTER INTEGRATED DRILL GUIDE
0084091615987042MM LOLIPOP TRIALS
00840916159757ZEUS-A BROACH HEAD, 16MM -7°
00840916159740ZEUS-A BROACH HEAD, 14MM -7°
00840916159733ZEUS-A BROACH HEAD, 12MM -7°
00840916159726ZEUS-A BROACH HEAD, 10MM -7°
00840916159719ZEUS-A BROACH HEAD, 8MM -7°
00840916159702ZEUS-A OSTEOTOME, 16MM WIDE
00840916159696ZEUS-A OSTEOTOME, 14MM WIDE
00840916159689ZEUS-A OSTEOTOME, 10MM WIDE
00840916159672ZEUS-A OSTEOTOME, 8MM WIDE
00840916159665ZEUS-A ANTERIOR LUMBAR TRIAL, 14MM - 7°
00840916159658ZEUS-A ANTERIOR LUMBAR TRIAL, 12MM - 7°
00840916159641ZEUS-A ANTERIOR LUMBAR TRIAL, 8MM - 7°
00840916159634ZEUS-A ANTERIOR LUMBAR TRIAL, 8MM - 7°
00840916158491ZEUS-A POPSICLE TRIAL CONNECTED TO OBLIQUE HOLE
00840916146474Zeus-A Cage Trial 42mm x 25mm x 22mm, 13°
00840916146467Zeus-A Cage Trial 42mm x 25mm x 20mm, 13°
00840916146450Zeus-A Cage Trial 42mm x 25mm x 18mm, 13°
00840916146443Zeus-A Cage Trial 42mm x 25mm x 16mm, 13°
00840916146436Zeus-A Cage Trial 42mm x 25mm x 14mm, 13°
00840916146429Zeus-A Cage Trial 42mm x 25mm x 10mm, 7°
00840916146412Zeus-A Cage Trial 42mm x 25mm x 10mm, 13°
00840916146405Zeus-A Cage Trial 42mm x 25mm x 8mm, 13°
00840916146399Zeus-A Cage Trial 42mm x 25mm x 22mm, 7°
00840916146382Zeus-A Cage Trial 42mm x 25mm x 20mm, 7°
00840916146375Zeus-A Cage Trial 42mm x 25mm x 18mm, 7°
00840916146368Zeus-A Cage Trial 42mm x 25mm x 16mm, 7°
00840916146351Zeus-A Cage Trial 42mm x 25mm x 14mm, 7°
00840916146344Zeus-A Cage Trial 42mm x 25mm x 12mm, 7°
00840916146337Zeus-A Cage Trial 42mm x 25mm x 10mm, 7°
00840916146320Zeus-A Cage Trial 42mm x 25mm x 8mm, 7°
00840916146313Zeus-A Cage 42mm x 25mm x 20mm, 13°
00840916146306Zeus-A Cage 42mm x 25mm x 22mm, 7°
00840916146290Zeus-A Cage 42mm x 25mm x 20mm, 7°
00840916146283Zeus-A Inserter
00840916146276Curved Chisel
00840916146269ZEUS-A CADDY, 13 DEGREE
00840916146252ZEUS-A CADDY, 7 DEGREE
00840916146245Zeus-A Trial Handle

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