FDA.reportPublic FDA data

Piccolo Composite Plate System

Primary DI
07290110201487
Brand
Piccolo Composite Plate System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Screw Holder
Catalog number
PL921630
Device description
Holding device for use with the Piccolo Composite MTP Plate System
Published
2017-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K170401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170401000Piccolo Composite® Plate SystemCarboFix Orthopedics , Ltd.2017-05-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110201487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110201487072901102014877290110201487

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649185170
Device count
1
Lot or batch
true
Sterilization required before use
true

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07290117356951CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40282026-03-25
07290117356968CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40302026-03-25
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