FDA.reportPublic FDA data

Piccolo Composite Plate System

Primary DI
07290110205065
Brand
Piccolo Composite Plate System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Lapidus Plate
Catalog number
LAP100001
Device description
A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
Published
2018-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182015000Piccolo Composite® Plate SystemCarboFix Orthopedics , Ltd.2018-10-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110205065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110205065072901102050657290110205065

GMDN Terms#

Term, Definition table
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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length36Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97299511511info@carbo-fix.com
1-800-408-0120usa@carbo-fix.com

Regulatory Flags#

DUNS number
649185170
Device count
1
Lot or batch
true
Expiration date on label
true

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