FDA.reportPublic FDA data

GUIDED GROWTH PLATE SYSTEM

Primary DI
18054242518051
Brand
GUIDED GROWTH PLATE SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
180015
Device description
GUIDED GROWTH PLATE BENDER
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
18054242518051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251805118054242518051

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

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
18053504361176TRUELOK SYSTEM154-115602018-04-28
18059015376654MINIRAL1M191-012026-05-04
18059015376661MINIRAL1M191-022026-05-04
18059015376678MINIRAL1M1912026-05-04
18059015376692PENNIG MINIFIXATOR1M444-012026-05-04
18059015376708PENNIG MINIFIXATOR1M444-022026-05-04
18059015376715PENNIG MINIFIXATOR1M4442026-05-04
18059015376784PENNIG DYNAMIC WRIST FIXATOR113761-012026-05-04
18059015376791PENNIG DYNAMIC WRIST FIXATOR113761-022026-05-04
18059015376807PENNIG DYNAMIC WRIST FIXATOR113761-032026-05-04
18059015376814PENNIG DYNAMIC WRIST FIXATOR1137612026-05-04
18054242515173Galaxy UNYCO System199-936732016-07-27
18054242515180Galaxy UNYCO System199-936702016-07-27
18052469476055ORTHOFIX MODULSYSTEM1M1462022-12-27
18052469476086ORTHOFIX MODULSYSTEM199-M1462022-12-27
18052469476406ORTHOFIX MODULSYSTEM199-M14602022-12-27
18053504369721ORTHOFIX GALAXY FIXATION SYSTEM1930402019-05-31
18053504369738ORTHOFIX GALAXY FIXATION SYSTEM1931402019-05-31
18059015375879TrueLok Elevate150-2590C2025-01-03
18059015375909TrueLok Elevate150-25052025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G791EFC0212S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0212T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0216S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0216T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0220S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0220T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0222S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0222T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0224S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0224T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0414S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0414T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0416S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0416T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0422S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0422T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0426S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0426T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0432S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0432T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212ST080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216ST080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0220S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0220SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06