FDA.reportPublic FDA data

GUIDED GROWTH PLATE SYSTEM

Primary DI
18054242518020
Brand
GUIDED GROWTH PLATE SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
180005
Device description
DRILL GUIDE
Published
2018-04-18
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
OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBTPlate, Bone, Growth Control, Pediatric, EpiphysiodesisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172183000Guided Growth Plate System PlusOrthofix Srl2018-01-09OBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054242518020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251802018054242518020

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015375831OrthoNext™ Platform System Software2.1ORTHONEXTSW2.12025-01-31
18059015375848OrthoNext™ Platform System Software1.1TLHEXMODULESW1.12025-01-31
18052469476444OrthoNext™ Platform System Software1.0TLHEXMODULESW2023-03-31
18052469476451OrthoNext™ Platform System Software1.0MYHEXPLANSW2023-03-31
18053340345675OrthoNext™ Platform System Software2.0ORTHONEXTSW2023-03-31
18053340345682OrthoNext™ Platform System Software1.1JPSMODULESW2023-03-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B562PKEFC0416S080WishFIXWishbone Medical, Inc.OBT2023-03-16
B562XKEFC0414S080WishFIXWishbone Medical, Inc.OBT2021-12-21
B562XKEFC0414SS080WishFIXWishbone Medical, Inc.OBT2021-12-21
B562XKEFC0414ST080WishFIXWishbone Medical, Inc.OBT2021-12-21
B562XKEFC0414T080WishFIXWishbone Medical, Inc.OBT2021-12-21
B562XKEFC0414T08US0WishFIXWishbone Medical, Inc.OBT2021-12-21
B562PKEFC0414S080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414S08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414SS080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414SS08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414ST080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414ST08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414T080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0414T08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416S08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416SS080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416SS08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416ST080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416ST08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416T080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0416T08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422S080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422S08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422SS080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422SS08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422ST080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422ST08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422T080WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0422T08US0WishFIXWishbone Medical, Inc.OBT2021-12-20
B562PKEFC0426S080WishFIXWishbone Medical, Inc.OBT2021-12-20