FDA.report

Flower Orthopedics

Primary DI
00840118122467
Brand
Flower Orthopedics
Company
FLOWER ORTHOPEDICS CORPORATION
Model
RAD321
Catalog number
RAD321
Device description
Radius Plate, Bowed, 21-Hole, 276mm
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118122467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118122467008401181224678401181224670840118122467

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(877)778-8587info@flowerortho.com

Regulatory Flags

DUNS number
078790947
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840118124188Flower OrthopedicsOC450802025-01-28
00840118124195Flower OrthopedicsOC450852025-01-28
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00840118124393Flower OrthopedicsOC650352025-01-28
00840118124409Flower OrthopedicsOC650402025-01-28
00840118124430Flower OrthopedicsOC650552025-01-28
00840118124447Flower OrthopedicsOC650602025-01-28
00840118124454Flower OrthopedicsOC650652025-01-28
00840118124478Flower OrthopedicsOC650752025-01-28
00840118124485Flower OrthopedicsOC650802025-01-28

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