FDA.reportPublic FDA data

Neo Medical Pedicle screw kit

Primary DI
07640177820129
Brand
Neo Medical Pedicle screw kit
Company
Neo Medical SA
Model
SC-70-45-PE
Catalog number
SC-70-45-PE
Device description
Pedicle screw kit 2x(Ø7.0 x 45mm)
Published
2017-10-27
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
K171582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171582000NEO Pedicle Screw System™Neo Medical SA2017-09-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177820129PrimaryGS10
B206SC7045PE0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177820129076401778201297640177820129

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended 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 (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Outer Diameter7Millimeter

Storage And Handling#

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

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
07640177821188Neo Medical Pedicle Screw SystemSI-PM-40-002023-01-26
07640177820679Neo Medical Pedicle Screw SystemSI-PM-IN-NS2020-08-31
07640177821324Neo Medical Pedicle screw kitTP-10-00-XL2026-02-09
07640177820938Neo Medical Pedicle screw kitSI-RW-00-NS2025-11-04
07640177822376Neo Medical Cage kitAS-22-07-04AS-22-07-042020-01-06
07640177822383Neo Medical cage KitAS-22-09-04AS-22-09-042020-01-06
07640177822390Neo Medical Cage kitAS-22-11-04AS-22-11-042020-01-06
07640177822406Neo Medical Cage kitAS-22-13-04AS-22-13-042020-01-06
07640177822413Neo Medical Cage kitAS-22-07-08AS-22-07-082020-01-06
07640177822420Neo Medical Cage kitAS-22-09-08AS-22-09-082020-01-06
07640177822437Neo Medical Cage kitAS-22-11-08AS-22-11-082020-01-06
07640177822444Neo Medical Cage kitAS-22-13-08AS-22-13-082020-01-06
07640177822451Neo Medical Cage kitAS-32-07-00AS-32-07-002020-01-06
07640177822468Neo Medical Cage kitAS-32-09-00AS-32-09-002020-01-06
07640177822475Neo Medical Cage kitAS-32-11-00AS-32-11-002020-01-06
07640177822482Neo Medical Cage kitAS-32-13-00AS-32-13-002020-01-06
07640177822499Neo Medical Cage kitAC-32-07-05AC-32-07-052020-01-06
07640177822505Neo Medical Cage kitAC-32-08-05AC-32-08-052020-01-06
07640177822512Neo Medical Cage kitAC-32-09-05AC-32-09-052020-01-06
07640177822529Neo Medical Cage kitAC-32-10-05AC-32-10-052020-01-06

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