FDA.reportPublic FDA data

Piccolo Composite Plate System

Primary DI
07290109339351
Brand
Piccolo Composite Plate System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Depth Gauge
Catalog number
PLDF0240
Device description
Depth Gauge for use with the Piccolo Composite Distal Fibula and One-Third Tubular Plate Systems
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120409000PICCOLO COMPOSITE PLATE SYSTEMCarboFix Orthopedics , Ltd.2012-11-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109339351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109339351072901093393517290109339351

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117353738CarboClear Hybrid Pedicle Screw SystemMIS Rod FeelerHYB0102026-07-27
07290117352113CarboClear Hybrid Pedicle Screw SystemMIS Rod FeelerHYBM112024-07-15
07290117359549CarboClear Posterior Cervical Screw SystemShaped Rod - Type ACRC40012026-07-13
07290117359563CarboClear Posterior Cervical Screw SystemShaped Rod - Type BCRC40022026-07-13
07290117351024CarboClear Posterior Cervical Screw SystemDrill BitCS0122024-06-05
07290110209780CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5020N2021-06-29
07290110209797CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5025N2021-06-28
07290110209803CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5030N2021-06-28
07290110209810CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5035N2021-06-28
07290110209827CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5040N2021-06-28
07290110209834CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5045N2021-06-28
07290123860107CarboClear Posterior Cervical Screw SystemHybrid Angle AdjusterHCS062026-03-30
07290123860114CarboClear Posterior Cervical Screw SystemHybrid Counter TorqueHCS072026-03-30
07290117356869CarboClear Posterior Cervical Screw SystemSet ScrewHCS40002026-03-25
07290117356906CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40182026-03-25
07290117356913CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40202026-03-25
07290117356920CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40222026-03-25
07290117356937CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40242026-03-25
07290117356944CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40262026-03-25
07290117356951CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40282026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620971Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620575Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26