FDA.reportPublic FDA data

Guided Growth Plate System

Primary DI
18054242518334
Brand
Guided Growth Plate System
Company
ORTHOFIX SRL
Model
1
Catalog number
99-T80216
Device description
GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L16MM STERILE
Published
2017-05-22
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

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
K093442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093442000GUIDED GROWTH SYSTEMOrthofix, Inc.2010-06-10OBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054242518334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251833418054242518334

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
Length16Millimeter

Sterilization Methods#

Method table
Method

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
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
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