FDA.report

Low Profile Locking Plate, 7 Holes

Primary DI
00840118112031
Brand
Low Profile Locking Plate, 7 Holes
Company
FLOWER ORTHOPEDICS CORPORATION
Model
FFP 087
Device description
implants for orthopedic bone fixation
Published
2016-12-08
Public version status
Update
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

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118112031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118112031008401181120318401181120310840118112031

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Device Sizes

TypeValueUnit
Height1.7Millimeter

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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00840118124478Flower OrthopedicsOC650752025-01-28
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