FDA.reportPublic FDA data

Montblanc Cortical Screw

Primary DI
08809958989274
Brand
Montblanc Cortical Screw
Company
MEDIFIELD MEDICAL Co., Ltd.
Model
35C-028
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243368000Montblanc Plate SystemMedifield Medical Co., Ltd.2025-06-04HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800274098626PackageGS110In Commercial Distribution
08809958989274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800274098626088002740986268800274098626
08809958989274088099589892748809958989274

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+821089806787medifield329@gmail.com

Regulatory Flags#

DUNS number
695956893
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800274091061Montblanc Depth GaugeRFM0592026-06-22
08800274099555Tray for Montblanc Radius Plate SystemMF0022026-06-22
08809958987065Montblanc Depth GaugeRFM0102026-06-22
08809958987072Montblanc Driver ShaftRFM0042026-06-22
08809958987089Montblanc Driver ShaftRFM0232026-06-22
08809958987096Montblanc Plate TackRFM0072026-06-22
08809958987126Montblanc Cortical Drill GuideRFM0022026-06-22
08809958987133Montblanc Cortical Drill GuideRFM0172026-06-22
08809958987140Montblanc Lag Drill GuideRFM0182026-06-22
08809958987157Montblanc Locking Drill SleeveRFM0062026-06-22
08809958987164Montblanc Locking Drill SleeveRFM0192026-06-22
08809958987171Montblanc Guide Block Drill GuideRFM0052026-06-22
08809958987188Montblanc Guide Block - NarrowRFM0112026-06-22
08809958987195Montblanc Guide Block - NarrowRFM0122026-06-22
08809958987201Montblanc Guide Block - StandardRFM0132026-06-22
08809958987218Montblanc Guide Block - StandardRFM0142026-06-22
08809958987225Montblanc Guide Block - WideRFM0152026-06-22
08809958987232Montblanc Guide Block - WideRFM0162026-06-22
08809958987256Montblanc AO Type HandleRFM0012026-06-22
08809958987263Montblanc Drill BitRFM0032026-06-22

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