FDA.reportPublic FDA data

GUIDED GROWTH PLATE SYSTEM

Primary DI
18054242518396
Brand
GUIDED GROWTH PLATE SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
99-T80316
Device description
GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L16MM D3.5MM STERILE
Published
2019-05-30
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
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
K180624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180624000Guided Growth Plate System PlusOrthofix Srl2018-05-15OBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054242518396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251839618054242518396

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method

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
Expiration date on label
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

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Primary DI, Brand, Company table
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G791PKEFC0220S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
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