WishFIX

Primary DI
B562XKEFC0416SS080
Brand
WishFIX
Company
Wishbone Medical, Inc.
Model
XK-EFC0416SS-08
Catalog number
XK-EFC0416SS
Device description
Express Kit, Curved 4-Hole x 16mm WishFIX Plate, Instruments and Solid Screws, SS
Published
2021-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B562XKEFC0416SS080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Regulatory Flags#

DUNS number
062355158
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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