Distal Radius Plate, Narrow, Right, 3 Holes

GUDID 00840118109925

Implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00840118109925
NIH Device Record Key4d3f6f20-0c33-4267-8eb6-4f473a1dad81
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Radius Plate, Narrow, Right, 3 Holes
Version Model NumberFDR 002
Company DUNS078790947
Company NameFLOWER ORTHOPEDICS CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com

Device Dimensions

Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter
Height2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118109925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-13

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

00840118119610 - Flower Orthopedics2024-04-15 Screw Washer- For 2.7/3.5/4.0 Screws, 10mm
00840118119634 - Flower Orthopedics2024-04-15 2.7mm x 8mm Locking Screw
00840118119641 - Flower Orthopedics2024-04-15 2.7mm x 10mm Locking Screw
00840118119658 - Flower Orthopedics2024-04-15 2.7mm x 12mm Locking Screw
00840118119665 - Flower Orthopedics2024-04-15 2.7mm x 14mm Locking Screw
00840118119672 - Flower Orthopedics2024-04-15 2.7mm x 16mm Locking Screw
00840118119689 - Flower Orthopedics2024-04-15 2.7mm x 18mm Locking Screw
00840118119696 - Flower Orthopedics2024-04-15 2.7mm x 20mm Locking Screw

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