Omni Stable AF

GUDID 00842078122822

Anterior Tibia Plate, 17 Holes (7 Proximal)

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00842078122822
NIH Device Record Keya9c94fbf-882f-4a5a-b14d-fd94f087a1e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni Stable AF
Version Model Number155-24700
Company DUNS832720358
Company NameEXTREMITY MEDICAL, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842078122822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

[00842078122822]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

On-Brand Devices [Omni Stable AF]

00842078130148Straight Plate, 2 Holes
00842078130117Hook Plate, 7 Holes (5 Proximal)
00842078130100Hook Plate, 5 Holes (3 Proximal)
00842078130094Posterior Fibula Plate, 13 Holes (9 Proximal), Right
00842078130087Posterior Fibula Plate, 13 Holes (9 Proximal), Left
00842078130070Posterior Fibula Plate, 11 Holes (7 Proximal), Right
00842078130063Posterior Fibula Plate, 11 Holes (7 Proximal), Left
00842078130056Posterior Fibula Plate, 9 Holes (5 Proximal), Right
00842078130049Posterior Fibula Plate, 9 Holes (5 Proximal), Left
00842078130018Lateral Fibula Plate, 15 Holes (9 Proximal), Right
00842078130001Lateral Fibula Plate, 15 Holes (9 Proximal), Left
00842078129999Lateral Fibula Plate, 13 Holes (7 Proximal), Right
00842078129982Lateral Fibula Plate, 13 Holes (7 Proximal), Left
00842078129975Lateral Fibula Plate, 11 Holes (5 Proximal), Right
00842078129968Lateral Fibula Plate, 11 Holes (5 Proximal), Left
00842078126059Posterior Fibula Plate, 15 Holes (11 Proximal), Right
00842078126042Lateral Fibula Plate, 19 Holes (13 Proximal), Right
00842078126011Posterior Fibula Plate, 15 Holes (11 Proximal), Left
00842078126004Lateral Fibula Plate, 19 Holes (13 Proximal), Left
00842078125984Straight Plate, 16 Holes
00842078125953Straight Plate, 14 Holes
00842078124161Lateral Fibula Plate, 17 Holes (11 Proximal), Right
00842078124154Lateral Fibula Plate, 17 Holes (11 Proximal), Left
00842078122822Anterior Tibia Plate, 17 Holes (7 Proximal)
00842078122815Anterior Tibia Plate, 15 Holes (5 Proximal)
00842078122778Posterior Tibia Plate, L-Shape, 9 Holes (7 Proximal), Right
00842078122761Posterior Tibia Plate, L-Shape, 9 Holes (7 Proximal), Left
00842078122754Posterior Tibia Plate, L-Shape, 7 Holes (5 Proximal), Right
00842078122747Posterior Tibia Plate, L-Shape, 7 Holes (5 Proximal), Left
00842078122730Posterior Tibia Plate, L-Shape, 5 Holes (3 Proximal), Right
00842078122723Posterior Tibia Plate, L-Shape, 5 Holes (3 Proximal), Left
00842078122709Posterior Tibia Plate, Y-Shape, 9 Holes (7 Proximal)
00842078122693Posterior Tibia Plate, Y-Shape, 7 Holes (5 Proximal)
00842078122686Posterior Tibia Plate, Y-Shape, 5 Holes (3 Proximal)
00842078122679Straight Plate, 12 Holes
00842078122662Straight Plate, 10 Holes
00842078122655Straight Plate, 8 Holes
00842078122648Straight Plate, 6 Holes
00842078122631Straight Plate, 4 Holes
00842078128565Locking Screw - 2.8 x 60mm
00842078128558Non-Locking Screw - 2.8 x 60mm
00842078128480Locking Screw - 2.8 x 58mm
00842078128473Non-Locking Screw - 2.8 x 58mm
00842078128404Locking Screw - 2.8 x 56mm
00842078128398Non-Locking Screw - 2.8 x 56mm
00842078128329Locking Screw - 2.8 x 54mm
00842078128312Non-Locking Screw - 2.8 x 54mm
00842078128244Locking Screw - 2.8 x 52mm
00842078128237Non-Locking Screw - 2.8 x 52mm
00842078128169Locking Screw - 2.8 x 50mm
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