120mm Locking Lateral Distal Fibula Plate Right 314-9120R

GUDID 00810074302388

120mm Locking Lateral Distal Fibula Plate Right

Osteocentric Technologies, Inc.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810074302388
NIH Device Record Key80b193fe-209b-4818-bf99-9f7a4deef9fc
Commercial Distribution StatusIn Commercial Distribution
Brand Name120mm Locking Lateral Distal Fibula Plate Right
Version Model Number314-9120R
Catalog Number314-9120R
Company DUNS089645059
Company NameOsteocentric Technologies, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Length120 Millimeter
Length120 Millimeter
Length120 Millimeter
Length120 Millimeter
Length120 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810074302388 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074302388]

Moist Heat or Steam Sterilization


[00810074302388]

Moist Heat or Steam Sterilization


[00810074302388]

Moist Heat or Steam Sterilization


[00810074302388]

Moist Heat or Steam Sterilization


[00810074302388]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-17
Device Publish Date2024-12-09

Devices Manufactured by Osteocentric Technologies, Inc.

00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left2024-12-17 120mm Locking Lateral Distal Fibula Plate Left
00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left2024-12-17 140mm Locking Lateral Distal Fibula Plate Left
00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right2024-12-17120mm Locking Lateral Distal Fibula Plate Right
00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right2024-12-17 120mm Locking Lateral Distal Fibula Plate Right
00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right2024-12-17 140mm Locking Lateral Distal Fibula Plate Right
00810074305013 - 4.0 x 125mm Drill Bit Cann AO2024-12-16 4.0 x 125mm Drill Bit Cann AO
00810074306119 - 2.8 x 125mm Drill Bit Cann AO 2024-12-16 2.8 x 125mm Drill Bit Cann AO
00810074306133 - 1.6mm Guide Wire Smooth Trocar 150mm2024-12-16 1.6mm Guide Wire Smooth Trocar 150mm
00810074306140 - 1.6mm Guide Wire Smooth Trocar 230mm2024-12-16 1.6mm Guide Wire Smooth Trocar 230mm

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