FDA.reportPublic FDA data

PRIMA Proximal Femur Locking Plate System

Primary DI
B562PKPF350000
Brand
PRIMA Proximal Femur Locking Plate System
Company
Wishbone Medical, Inc.
Model
PK-PF3500-0
Device description
Proximal Femur Locking Plate Procedure Kit, 3.5mm
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
B562PKPF350000PrimaryHIBCC0

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
true
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
B56211113030006S10PRIMA Proximal Femur Locking Plate System11-113-030006S-12023-04-12
B56211113030012S10PRIMA Proximal Femur Locking Plate System11-113-030012S-12023-04-12
B56211113040006S10PRIMA Proximal Femur Locking Plate System11-114-040006S-12023-04-12
B56211113040014S10PRIMA Proximal Femur Locking Plate System11-114-040014S-12023-04-12
B56211113130006S10PRIMA Proximal Femur Locking Plate System11-113-130006S-12023-04-12
B56211113130012S10PRIMA Proximal Femur Locking Plate System11-113-130012S-12023-04-12
B56211113140006S10PRIMA Proximal Femur Locking Plate System11-114-140006S-12023-04-12
B56211113140014S10PRIMA Proximal Femur Locking Plate System11-114-140014S-12023-04-12
B56211113301800S10PRIMA Proximal Femur Locking Plate System11-113-301800S-12023-04-12
B56211113331800S01PRIMA Proximal Femur Locking Plate System11-113-331800S-12023-04-12
B56211113331800S10PRIMA Proximal Femur Locking Plate System11-114-331800S-12023-04-12
B56211113341800S10PRIMA Proximal Femur Locking Plate System11-113-341800S-12023-04-12
B56211113361800S10PRIMA Proximal Femur Locking Plate System11-113-361800S-12023-04-12
B56211113381800S10PRIMA Proximal Femur Locking Plate System11-113-381800S-12023-04-12
B56211113431800S10PRIMA Proximal Femur Locking Plate System11-113-431800S-12023-04-12
B56211113441800S10PRIMA Proximal Femur Locking Plate System11-114-441800S-12023-04-12
B56211113930006S10PRIMA Proximal Femur Locking Plate System11-113-930006S-12023-04-12
B56211113930012S10PRIMA Proximal Femur Locking Plate System11-113-930012S-12023-04-12
B56211113930014S10PRIMA Proximal Femur Locking Plate System11-114-930014S-12023-04-12
B56211114301800S10PRIMA Proximal Femur Locking Plate System11-114-301800S-12023-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606798Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606804Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606811Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606828Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606835Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606842Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606859Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606866Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606873Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606880Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30