FDA.reportPublic FDA data

Neo Medical Pedicle Screw System

Primary DI
07640177821041
Brand
Neo Medical Pedicle Screw System
Company
Neo Medical SA
Model
SC-80-35-PE
Device description
Pedicle screw kit 2x(Ø8.0 x 35mm)
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222256000BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA2022-08-26PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177821041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177821041076401778210417640177821041

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Outer Diameter8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486778843
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640177820907Neo Medical Pedicle screw kitSI-MB-00-002026-07-10
07640177821393Neo Medical Pedicle screw kitSS-BS-00-NS2026-07-10
07640177821409Neo Medical Pedicle screw kitSS-CS-01-NS2026-07-10
07640177821416Neo Medical Pedicle screw kitSS-CS-02-NS2026-07-10
07640177823564Neo Medical RetractorsRP-00-40-002026-07-10
07640177823571Neo Medical RetractorsRP-00-50-002026-07-10
07640177823588Neo Medical RetractorsRP-00-60-002026-07-10
07640177823595Neo Medical RetractorsRP-00-70-002026-07-10
07640177823601Neo Medical RetractorsRP-00-80-002026-07-10
07640177823748Neo Medical RetractorsRP-00-40-BL2026-07-10
07640177823755Neo Medical RetractorsRP-00-50-BL2026-07-10
07640177823762Neo Medical RetractorsRP-00-60-BL2026-07-10
07640177823779Neo Medical RetractorsRP-00-70-BL2026-07-10
07640177823786Neo Medical RetractorsRP-00-80-BL2026-07-10
07640177823793Neo Medical RetractorsRP-00-90-BL2026-07-10
07640177823809Neo Medical RetractorsRP-00-AK-002026-07-10
07640177823816Neo Surgical LightsSL-20-00-FL2026-07-10
07640177823007Neo Medical RetractorsRL-01-20-NS2024-02-06
07640177823021Neo Medical RetractorsRL-01-60-NS2024-02-06
07640177823038Neo Medical RetractorsRL-01-80-NS2024-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28