FDA.reportPublic FDA data

The Y3 Locking Trochanteric Plating System

Primary DI
07540194006219
Brand
The Y3 Locking Trochanteric Plating System
Company
Orthopediatrics Canada ULC
Model
Y3P-IML-235
Catalog number
Y3P-IML-235
Device description
Y3 PLATE 235MM - LEFT
Published
2018-12-12
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163003000Y3 Proximal Femoral Plate SystemPega Medical, Inc.2017-03-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194006219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194006219075401940062197540194006219

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length235Millimeter

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
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
B562PKSMC0635NSLTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
B562PKSMC0635NSRTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
B562MPKCSST4036T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4036TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4038T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4038TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4040T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4040TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562PKTCX27LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SMUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02