FDA.reportPublic FDA data

GIRO GROWTH MODULATION SYSTEM

Primary DI
07540194014320
Brand
GIRO GROWTH MODULATION SYSTEM
Company
Orthopediatrics Canada ULC
Model
GRO-A45-024
Catalog number
GRO-A45-024
Device description
4.5 GIRO 24mm
Published
2023-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K220190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220190000The GIRO Growth Modulation SystemPega Medical, Inc.2022-10-24OBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194014320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194014320075401940143207540194014320

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(450)688-5144egarcia@orthopediatrics.ca

Regulatory Flags#

DUNS number
243298854
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540194018168Dr.Paleys Osteotomy SystemDRPO-706DRPO-7062026-03-11
07540194013163The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100-CPOP-IMP100-C2021-11-30
07540194008916The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-CAP100POP-CAP1002020-08-12
07540194009067The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100POP-IMP1002020-08-12
07540194002181GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP015GAP-CP0152016-10-20
07540194002198GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP050GAP-CP0502016-10-20
07540194002204GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP100GAP-CP1002016-10-20
07540194002396FREE GLIDING SCFE SCREW SYSTEMSCF-MC-065SCF-MC-0652016-10-20
07540194002570FREE GLIDING SCFE SCREW SYSTEMSCF-MC-073SCF-MC-0732016-10-20
07540194004215SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-315SLM-CAP-3152016-10-20
07540194004222SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-350SLM-CAP-3502016-10-20
07540194004239SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-415SLM-CAP-4152016-10-20
07540194004246SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-450SLM-CAP-4502016-10-20
07540194009982GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG2GAP-KDG360-PKG22020-08-12
07540194009999GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG6GAP-KDG360-PKG62020-08-12
07540194016737GAP ENDO-EXO MEDULLARY SYSTEMGAP-SDG200GAP-SDG2002024-06-13
07540194009975GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360GAP-KDG3602020-08-12
07540194017956GIRO GROWTH MODULATION SYSTEMGRO-CYF250-35GRO-CYF250-352025-03-31
07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11

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