FDA.reportPublic FDA data

Neo Pedicle Screw Kit

Primary DI
07640177820518
Brand
Neo Pedicle Screw Kit
Company
Neo Medical SA
Model
SC-45-25-PE
Device description
Pedicle screw kit 2x(Ø4.5 x 25mm)
Published
2021-11-26
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
K212489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212489000BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA2021-10-28PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177820518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177820518076401778205187640177820518

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter4.5Millimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05