FDA.reportPublic FDA data

PRIMA Proximal Femur Locking Plate System

Primary DI
B56211114930006S10
Brand
PRIMA Proximal Femur Locking Plate System
Company
Wishbone Medical, Inc.
Model
11-114-930006S-1
Device description
4.5mm Proximal Femur Plate, 90°, 3 hole, 6mm offset, SS
Published
2023-04-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230527000WishBone Medical Plate and Screw SystemWishbone Medical, Inc.2023-03-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B56211114930006S10PrimaryHIBCC0

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
(574) 306-4006WeCare@WishBoneMedical.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B562TCX27008US02.7mm x 8mm Ti Cortical ScrewTCX27008-USTCX270082019-11-25
B562TCX27010US02.7mm x 10mm Ti Cortical ScrewTCX27010-USTCX270102019-11-25
B562TCX27012US02.7mm x 12mm Ti Cortical ScrewTCX27012-USTCX270122019-11-25
B562TCX27014US02.7mm x 14mm Ti Cortical ScrewTCX27014-USTCX270142019-11-25
B562TCX27016US02.7mm x 16mm Ti Cortical ScrewTCX27016-USTCX270162019-11-25
B562TCX27018US02.7mm x 18mm Ti Cortical ScrewTCX27018-USTCX270182019-11-25
B562TCX27020US02.7mm x 20mm Ti Cortical ScrewTCX27020-USTCX270202019-11-25
B562TCX27022US02.7mm x 22mm Ti Cortical ScrewTCX27022-USTCX270222019-11-25
B562TCX27024US02.7mm x 24mm Ti Cortical ScrewTCX27024-USTCX270242019-11-25
B562TCX27026US02.7mm x 26mm Ti Cortical ScrewTCX27026-USTCX270262019-11-25
B562TCX27028US02.7mm x 28mm Ti Cortical ScrewTCX27028-USTCX270282019-11-25
B562TCX27030US02.7mm x 30mm Ti Cortical ScrewTCX27030-USTCX270302019-11-25
B562TCX27032US02.7mm x 32mm Ti Cortical ScrewTCX27032-USTCX270322019-11-25
B562TCX27034US02.7mm x 34mm Ti Cortical ScrewTCX27034-USTCX270342019-11-25
B562TCX27036US02.7mm x 36mm Ti Cortical ScrewTCX27036-USTCX270362019-11-25
B562TCX27038US02.7mm x 38mm Ti Cortical ScrewTCX27038-USTCX270382019-11-25
B562TCX27040US02.7mm x 40mm Ti Cortical ScrewTCX27040-USTCX270402019-11-25
B562TCX27045US02.7mm x 45mm Ti Cortical ScrewTCX27045-USTCX270452019-11-25
B562TCX27050US02.7mm x 50mm Ti Cortical ScrewTCX27050-USTCX270502019-11-25

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