FDA.reportPublic FDA data

GIRO GROWTH MODULATION SYSTEM

Primary DI
07540194013590
Brand
GIRO GROWTH MODULATION SYSTEM
Company
Orthopediatrics Canada ULC
Model
GRO-TPR145
Catalog number
GRO-TPR145
Device description
4.5 TISSUE PROTECTOR
Published
2022-11-29
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
LXHOrthopedic manual surgical instrument
OBTPlate, bone, growth control, pediatric, epiphysiodesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
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
07540194013590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194013590075401940135907540194013590

GMDN Terms#

Term, Definition table
TermDefinition
Growth-correction orthopaedic fixation plate kitA collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter4.8Millimeter
Outer Diameter6.5Millimeter

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@pegamedical.com

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
00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
B562PKEFC0416S080WishFIXWishbone Medical, Inc.OBT2023-03-16
B562PKOCD02010AlloMateWishbone Medical, Inc.LXH2023-03-16
B562PKOCD02510AlloMateWishbone Medical, Inc.LXH2023-03-16
B562PKOCD03010AlloMateWishbone Medical, Inc.LXH2023-03-16
B562PKOCD03510AlloMateWishbone Medical, Inc.LXH2023-03-16
B562PKOCD04010AlloMateWishbone Medical, Inc.LXH2023-03-16
B56251202101628G10WishFIXWishbone Medical, Inc.LXH2022-07-18
B56251904100709G10WishBone K-Wire SystemWishbone Medical, Inc.LXH2022-07-18
B56251904100912G10WishBone K-Wire SystemWishbone Medical, Inc.LXH2022-07-18
B56251904101216G10WishBone K-Wire SystemWishbone Medical, Inc.LXH2022-07-18
B56251904101620G10WishBone K-Wire SystemWishbone Medical, Inc.LXH2022-07-18
B56251904102025G10WishBone K-Wire SystemWishbone Medical, Inc.LXH2022-07-18
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