FDA.reportPublic FDA data

WishFIX

Primary DI
G791PKEFC0220S080
Brand
WishFIX
Company
Red Star Contract Manufacturing Inc.
Model
PK-EFC0220S-08
Catalog number
PK-EFC0220S-08
Device description
Procedure Kit, Curved 2-Hole x 20mm WishFIX Plate, Instruments and Screws, SS
Published
2025-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
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
G791PKEFC0220S080PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
(260) 327-3145customerservice@redstarcontractmfg.com

Regulatory Flags#

DUNS number
968145917
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
G791EFC0212S080WishFIXEFC0212S-08EFC0212S-082025-10-06
G791EFC0212T080WishFIXEFC0212T-08EFC0212T-082025-10-06
G791EFC0216S080WishFIXEFC0216S-08EFC0216S-082025-10-06
G791EFC0216T080WishFIXEFC0216T-08EFC0216T-082025-10-06
G791EFC0220S080WishFIXEFC0220S-08EFC0220S-082025-10-06
G791EFC0220T080WishFIXEFC0220T-08EFC0220T-082025-10-06
G791EFC0222S080WishFIXEFC0222S-08EFC0222S-082025-10-06
G791EFC0222T080WishFIXEFC0222T-08EFC0222T-082025-10-06
G791EFC0224T080WishFIXEFC0224T-08EFC0224T-082025-10-06
G791EFC0422T080WishFIXEFC0422T-08EFC0422T-082025-10-06
G791EFC0426S080WishFIXEFC0426S-08EFC0426S-082025-10-06
G791EFC0432S080WishFIXEFC0432S-08EFC0432S-082025-10-06
G791PKEFC0212S080WishFIXPK-EFC0212S-08PK-EFC0212S-082025-10-06
G791PKEFC0422S080WishFIXPK-EFC0422S-08PK-EFC0422S-082025-10-06
G791SEFSS16080WishFIXSEFSS16-08SEFSS16-082025-10-06
G791SEFSS20080WishFIXSEFSS20-08SEFSS20-082025-10-06
G791SEFSS24080WishFIXSEFSS24-08SEFSS24-082025-10-06
G791SEFSS28080WishFIXSEFSS28-08SEFSS28-082025-10-06
G791SEFSS32080WishFIXSEFSS32-08SEFSS32-082025-10-06
G791SEFSS36080WishFIXSEFSS36-08SEFSS36-082025-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G791EFC0212S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0212T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0216S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0216T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0220S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0220T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0222S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0222T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0224S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0224T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0414S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0414T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0416S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0416T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0422S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0422T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0426S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0426T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0432S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791EFC0432T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212ST080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0212T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216ST080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0216T080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0220SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0220ST080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06