FDA.reportPublic FDA data

Tempus™

Primary DI
00841508100133
Brand
Tempus™
Company
NEUROSTRUCTURES, INC
Model
10-02-034
Device description
2 LEVEL PLATE 34mm
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841508100133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508100133008415081001338415081001330841508100133

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8003526103customerservice@neurostructures.com

Regulatory Flags#

DUNS number
079391677
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841508100003Tempus™10-01-0122016-03-09
00841508100010Tempus™10-01-0142015-09-17
00841508100027Tempus™10-01-0162015-09-17
00841508100034Tempus™10-01-0182015-09-17
00841508100041Tempus™10-01-0202015-09-17
00841508100058Tempus™10-01-0222015-09-17
00841508100065Tempus™10-01-0242015-09-17
00841508100072Tempus™10-01-0262015-09-17
00841508100089Tempus™10-02-0242015-09-17
00841508100096Tempus™10-02-0262015-09-17
00841508100102Tempus™10-02-0282015-09-17
00841508100119Tempus™10-02-0302015-09-17
00841508100126Tempus™10-02-0322015-09-17
00841508100140Tempus™10-02-0372015-09-17
00841508100157Tempus™10-02-0402015-09-17
00841508100164Tempus™10-02-0432015-09-17
00841508100171Tempus™10-02-0462015-09-17
00841508100188Tempus™10-03-0392015-09-17
00841508100195Tempus™10-03-0422015-09-17
00841508100201Tempus™10-03-0452015-09-17

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Primary DI, Brand, Company table
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00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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