FDA.reportPublic FDA data

Neo Medical Pedicle Screw System

Primary DI
07640177820631
Brand
Neo Medical Pedicle Screw System
Company
Neo Medical SA
Model
SI-ST-35-00
Device description
Steffee 3.5 mm
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177820631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177820631076401778206317640177820631

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, single-useA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Millimeter

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
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
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10649111020247Sklar®SKLAR CORPORATIONHXB2018-09-14