FDA.reportPublic FDA data

PRIMA Femoral Locking Plate System

Primary DI
B56211902035014S10
Brand
PRIMA Femoral Locking Plate System
Company
Wishbone Medical, Inc.
Model
11-902-035014S-1
Device description
3.5mm x 14mm Solid, Locking Cortical Screw, SS
Published
2023-04-10
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, 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
B56211902035014S10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
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
00196449002511LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002528LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002535LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002542LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002559LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002566LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002634LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002658LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002665LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08