FDA.reportPublic FDA data

Sterile Spine Pedicle Screw System

Primary DI
B562090681NS0
Brand
Sterile Spine Pedicle Screw System
Company
Wishbone Medical, Inc.
Model
62-2677-10
Catalog number
62-2677-10
Device description
Ø5.5 Axial Rod Reducer, Adaptor, 1/4 sq
Published
2022-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192930000Dymaxeon Spine SystemBack 2 Basics Direct, LLC2020-05-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562090681NS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
062355158
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
18257200054206SFSOrthofix US LLCNKB2026-07-17
18257200054213SFSOrthofix US LLCNKB2026-07-17
18257200054220SFSOrthofix US LLCNKB2026-07-17
18257200054237SFSOrthofix US LLCNKB2026-07-17
18257200054244SFSOrthofix US LLCNKB2026-07-17
18257200054251SFSOrthofix US LLCNKB2026-07-17
18257200054268SFSOrthofix US LLCNKB2026-07-17
18257200054275SFSOrthofix US LLCNKB2026-07-17
18257200054282SFSOrthofix US LLCNKB2026-07-17
18257200054299SFSOrthofix US LLCNKB2026-07-17
18257200054305SFSOrthofix US LLCNKB2026-07-17
18257200054312SFSOrthofix US LLCNKB2026-07-17
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13