FDA.reportPublic FDA data

Neo Pedicle Screw System

Primary DI
07640177820754
Brand
Neo Pedicle Screw System
Company
Neo Medical SA
Model
RD-05-00-TI
Device description
Rod kit straight 500 mm (1x) - Titanium
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
07640177820754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177820754076401778207547640177820754

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
Length500Millimeter

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
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18