Spinema Lumbar Plate System 7301-5555S

GUDID 00840273302773

Variable Lumbar Plate Screw Cancellous Ø 5.5x 55mm

Aegis Spine, Inc.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID00840273302773
NIH Device Record Keyf32530cc-b7bc-48f2-972e-f8ca51082aaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinema Lumbar Plate System
Version Model Number7301-5555S
Catalog Number7301-5555S
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840273302773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-21
Device Publish Date2021-09-13

On-Brand Devices [Spinema Lumbar Plate System]

00840273301806Lumbar Plate 2 Hole 38mm
00840273301790Lumbar Plate 2 Hole 36mm
00840273301783Lumbar Plate 2 Hole 34mm
00840273301776Lumbar Plate 2 Hole 32mm
00840273301769Lumbar Plate 2 Hole 48mm
00840273301752Lumbar Plate 2 Hole 46mm
00840273301745Lumbar Plate 2 Hole 44mm
00840273301738Lumbar Plate 2 Hole 42mm
00840273301721Lumbar Plate 2 Hole 40mm
00840273301714Lumbar Plate 2 Hole 38mm
00840273301707Lumbar Plate 2 Hole 36mm
00840273301691Lumbar Plate 2 Hole 34mm
00840273301684Lumbar Plate 2 Hole 32mm
00840273302599Variable Lumbar Plate Screw Dual Thread Ø 5.5x 45mm
00840273302582Variable Lumbar Plate Screw Dual Thread Ø 5.5x 40mm
00840273302575Variable Lumbar Plate Screw Dual Thread Ø 5.5x 35mm
00840273302568Variable Lumbar Plate Screw Dual Thread Ø 5.5x 30mm
00840273302551Variable Lumbar Plate Screw Dual Thread Ø 5.5x 25mm
00840273302544Variable Lumbar Plate Screw Dual Thread Ø 5.5x 20mm
00840273302537Fixed Lumbar Plate Screw Cancellous Ø 6.0x 55mm
00840273302520Fixed Lumbar Plate Screw Cancellous Ø 6.0x 50mm
00840273302513Fixed Lumbar Plate Screw Cancellous Ø 6.0x 45mm
00840273302506Fixed Lumbar Plate Screw Cancellous Ø 6.0x 40mm
00840273302490Fixed Lumbar Plate Screw Cancellous Ø 6.0x 35mm
00840273302483Fixed Lumbar Plate Screw Cancellous Ø 6.0x 30mm
00840273302476Fixed Lumbar Plate Screw Cancellous Ø 6.0x 25mm
00840273302469Fixed Lumbar Plate Screw Cancellous Ø 6.0x 20mm
00840273302452Fixed Lumbar Plate Screw Cancellous Ø 5.5x 55mm
00840273302445Fixed Lumbar Plate Screw Cancellous Ø 5.5x 50mm
00840273302438Fixed Lumbar Plate Screw Cancellous Ø 5.5x 45mm
00840273302421Fixed Lumbar Plate Screw Cancellous Ø 5.5x 40mm
00840273302414Fixed Lumbar Plate Screw Cancellous Ø 5.5x 35mm
00840273302407Fixed Lumbar Plate Screw Cancellous Ø 5.5x 30mm
00840273302391Fixed Lumbar Plate Screw Cancellous Ø 5.5x 25mm
00840273302384Fixed Lumbar Plate Screw Cancellous Ø 5.5x 20mm
00840273302377Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 55mm
00840273302360Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 50mm
00840273302353Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 45mm
00840273302346Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 40mm
00840273302339Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 35mm
00840273302322Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 30mm
00840273302315Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 25mm
00840273302308Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 20mm
00840273302292Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 55mm
00840273302285Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 50mm
00840273302278Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 45mm
00840273302261Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 40mm
00840273302254Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 35mm
00840273302247Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 30mm
00840273302230Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 25mm

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