FDA.reportPublic FDA data

Neo Medical Pedicle Screw System

Primary DI
07640177820440
Brand
Neo Medical Pedicle Screw System
Company
Neo Medical SA
Model
SD-00-00-SS
Device description
Set-screwdriver
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177820440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177820440076401778204407640177820440

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
486778843
Device count
1
Premarket exempt
true
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
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24