FDA.reportPublic FDA data

Mercury

Primary DI
08406061016219
Brand
Mercury
Company
SPINAL ELEMENTS, INC.
Model
63245-080
Device description
Dia. 4.5 x 80mm Mercury Uniplanar Screw
Published
2019-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08406061016219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08406061016219084060610162198406061016219

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (760) 607 0121info@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606185110LUNA TiLUN20006-10T2026-09-25
00840606185127LUNA TiLUN20006-12T2026-09-25
00840606185134LUNA TiLUN20006-14T2026-09-25
00840606185141LUNA TiLUN20012-12T2026-09-25
00840606185158LUNA TiLUN20012-14T2026-09-25
00840606185165LUNA TiLUN20012-16T2026-09-25
00840606186223ALIF Disc Prep11044-0002026-09-25
00840606186230ALIF Disc Prep15161-0002026-09-25
00840606186261ALIF15163-0022026-09-25
00840606186278ALIF15163-0032026-09-25
00840606186285ALIF15163-0042026-09-25
00840606187381ALIF15301-0002026-09-25
00840606187565Ventana A40050-0202026-09-25
00840606187572Ventana A40050-0252026-09-25
00840606187589Ventana A40050-0302026-09-25
00840606187596Ventana A40050-0352026-09-25
00840606187602Ventana A40060-0202026-09-25
00840606187619Ventana A40060-0252026-09-25
00840606187633Ventana A40060-0352026-09-25
00840606196024Vertu53067-0012026-09-25

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Primary DI, Brand, Company table
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10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
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00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
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