ZESPIN SI Joint Fusion System 1022-1065S

GUDID 00840273311652

Arch Shape Screw (Open) 65mm

Aegis Spine, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile
Primary Device ID00840273311652
NIH Device Record Key47ef61bd-865c-4755-9870-03e8806daa63
Commercial Distribution StatusIn Commercial Distribution
Brand NameZESPIN SI Joint Fusion System
Version Model Number1022-1065S
Catalog Number1022-1065S
Company DUNS017993061
Company NameAegis Spine, Inc.
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840273311652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [ZESPIN SI Joint Fusion System]

00840273311577Washer Ø10x1.5mm
00840273311560Washer Ø9x1.5mm
00840273311553Washer Ø8x1.5mm
00840273311546Locking Screw Ø8x70mm
00840273311539Locking Screw Ø8x65mm
00840273311522Locking Screw Ø8x60mm
00840273311515Locking Screw Ø8x55mm
00840273311508Locking Screw Ø8x50mm
00840273311492Locking Screw Ø8x45mm
00840273311485Locking Screw Ø8x40mm
00840273311478Locking Screw Ø8x35mm
00840273311461Locking Screw Ø8x30mm
00840273311454Locking Screw Ø7x70mm
00840273311447Locking Screw Ø7x65mm
00840273311430Locking Screw Ø7x60mm
00840273311423Locking Screw Ø7x55mm
00840273311416Locking Screw Ø7x50mm
00840273311409Locking Screw Ø7x45mm
00840273311393Locking Screw Ø7x40mm
00840273311386Locking Screw Ø7x35mm
00840273311379Locking Screw Ø7x30mm
00840273311362Locking Screw Ø6x70mm
00840273311355Locking Screw Ø6x65mm
00840273311348Locking Screw Ø6x60mm
00840273311331Locking Screw Ø6x55mm
00840273311324Locking Screw Ø6x50mm
00840273311317Locking Screw Ø6x45mm
00840273311300Locking Screw Ø6x40mm
00840273311294Locking Screw Ø6x35mm
00840273311287Locking Screw Ø6x30mm
00840273311270Arch Shape Screw (Closed) 70mm
00840273311263Arch Shape Screw (Closed) 65mm
00840273311256Arch Shape Screw (Closed) 60mm
00840273311249Arch Shape Screw (Closed) 55mm
00840273311232Arch Shape Screw (Closed) 50mm
00840273311225Arch Shape Screw (Closed) 45mm
00840273311218Arch Shape Screw (Closed) 40mm
00840273311201Arch Shape Screw (Closed) 35mm
00840273311195Arch Shape Screw (Closed) 30mm
00840273311188Arch Shape Screw (Open) 70mm
00840273311171Arch Shape Screw (Open) 65mm
00840273311164Arch Shape Screw (Open) 60mm
00840273311157Arch Shape Screw (Open) 55mm
00840273311140Arch Shape Screw (Open) 50mm
00840273311133Arch Shape Screw (Open) 45mm
00840273311126Arch Shape Screw (Open) 40mm
00840273311119Arch Shape Screw (Open) 35mm
00840273311102Arch Shape Screw (Open) 30mm
00840273312246GRAFT IMPACTOR
00840273312239BONE GRAFT PACKING BLOCK
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