FDA.reportPublic FDA data

WishFIX

Primary DI
B562PKEFC0220ST080
Brand
WishFIX
Company
Wishbone Medical, Inc.
Model
PK-EFC0220ST-08
Catalog number
PK-EFC0220ST
Device description
Procedure Kit, Curved 2-Hole x 20mm WishFIX Plate, Instruments and Solid Screws, Ti
Published
2021-12-15
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

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
B562PKEFC0220ST080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
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
B56213904002520S10WishBone K-Wire System13-904-002520S-113-904-002520S-12022-07-18
B562PKKWELB0WishBone K-Wire SystemPK-KWELBPK-KWELB2020-12-02
B562PKKWELBUS0WishBone K-Wire SystemPK-KWELB-USPK-KWELB2020-12-02
B562PKKWEXT0WishBone K-Wire SystemPK-KWEXTPK-KWEXT2020-12-02
B562PKKWEXTUS0WishBone K-Wire SystemPK-KWEXT-USPK-KWEXT2020-12-02
B562KITKWIEXSML0Pediatric Extremity Combo K-Wire System-SMALLKIT-KWI-EXSML2019-03-28
B562KITKWIELBOW0Pediatric Elbow Combo K-Wire SystemKIT-KWI-ELBOW2019-03-18
B562KITKWIEXLAR0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXLAR2019-03-19
B562KITKWIEXMED0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXMED2019-03-19
B562KITKWILBONE0Pediatric Long Bone Combo K-Wire SystemKIT-KWI-LBONE2019-03-19

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
G791PKEFC0220S080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06
G791PKEFC0220SS080WishFIXRed Star Contract Manufacturing Inc.OBT2025-10-06