EpiFIX

Primary DI
B562XKEFC0212SSUS0
Brand
EpiFIX
Company
Wishbone Medical, Inc.
Model
XK-EFC0212SS-US
Catalog number
XK-EFC0212SS
Device description
Express Kit, Curved 2-Hole X 12mm EpiFIX Plate, Instruments and Solid Screws, SS
Published
2021-09-15
Public version status
Update
Distribution status
Not 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
K182704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182704000WishBone Guided Growth SystemWishbone Medical2019-06-25OBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562XKEFC0212SSUS0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062355158
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B562PKEFC0416S080WishFIXPK-EFC0416S-082023-03-16
B562PKOCD02010AlloMatePK-OCD020-12023-03-16
B562PKOCD02510AlloMatePK-OCD025-12023-03-16
B562PKOCD03010AlloMatePK-OCD030-12023-03-16
B562PKOCD03510AlloMatePK-OCD035-12023-03-16
B562PKOCD04010AlloMatePK-OCD040-12023-03-16
B562066582BWB0Sterile Spine Pedicle Screw System06.6582B-WB06.6582B-WB2022-07-19
B562066587BWB0Sterile Spine Pedicle Screw System06.6587B-WB06.6587B-WB2022-07-19
B56213904001220S00WishBone K-Wire System13-904-001220S-013-904-001220S-02022-07-18
B56213904001220S10WishBone K-Wire System13-904-001220S-113-904-001220S-12022-07-18
B56213904001620S00WishBone K-Wire System13-904-001620S-013-904-001620S-02022-07-18
B56213904001620S10WishBone K-Wire System13-904-001620S-113-904-001620S-12022-07-18
B56213904002020S00WishBone K-Wire System13-904-002020S-013-904-002020S-02022-07-18
B56213904002020S10WishBone K-Wire System13-904-002020S-113-904-002020S-12022-07-18
B56213904002520S00WishBone K-Wire System13-904-002520S-013-904-002520S-02022-07-18

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