FDA.report

Compression T-Plate, Oblique Right, 9 Holes, use with 1.5mm/2.0mm/2.4mm Screws

Primary DI
00840118114530
Brand
Compression T-Plate, Oblique Right, 9 Holes, use with 1.5mm/2.0mm/2.4mm Screws
Company
FLOWER ORTHOPEDICS CORPORATION
Model
FFP 209
Device description
implants for orthopedic bone fixation
Published
2018-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118114530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118114530008401181145308401181145300840118114530

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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