FDA.reportPublic FDA data

SOLE MEDIAL COLUMN FUSION PLATE

Primary DI
18053340346641
Brand
SOLE MEDIAL COLUMN FUSION PLATE
Company
ORTHOFIX SRL
Model
1
Catalog number
99-84010R
Device description
SOLE MCF SS PLATE STANDARD LARGE RIGHT STERILE
Published
2021-06-03
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
K210157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210157000SOLE Medial Column Fusion PlateOrthofix Srl2021-04-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18053340346641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805334034664118053340346641

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
Height2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23
18059015376944Fitbone Transport and Lengthening System199-600038282026-07-23
18059015376951Fitbone Transport and Lengthening System199-600038292026-07-23
18059015376968Fitbone Transport and Lengthening System199-600038302026-07-23
18059015376975Fitbone Transport and Lengthening System199-600038312026-07-23
18059015376982Fitbone Transport and Lengthening System199-600038322026-07-23
18059015376999Fitbone Transport and Lengthening System199-600038332026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
07613327649109T2, PANGEAStryker GmbHHRS2025-09-25
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07613327649277T2, PANGEAStryker GmbHHRS2025-09-25
07613327649284T2, PANGEAStryker GmbHHRS2025-09-25
07613327649291T2, PANGEAStryker GmbHHRS2025-09-25
07613327649307T2, PANGEAStryker GmbHHRS2025-09-25
07613327649314T2, PANGEAStryker GmbHHRS2025-09-25
07613327649321T2, PANGEAStryker GmbHHRS2025-09-25
07613327649338T2, PANGEAStryker GmbHHRS2025-09-25
07613327649345T2, PANGEAStryker GmbHHRS2025-09-25
07613327649352T2, PANGEAStryker GmbHHRS2025-09-25
07613327649369T2, PANGEAStryker GmbHHRS2025-09-25
07613327649376T2, PANGEAStryker GmbHHRS2025-09-25
07613327649383T2, PANGEAStryker GmbHHRS2025-09-25