FDA.reportPublic FDA data

Mercury

Primary DI
08406061004421
Brand
Mercury
Company
SPINAL ELEMENTS, INC.
Model
64065-030
Device description
Ø6.5 X 30mm Closed-Head Screw
Published
2019-02-26
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

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
08406061004421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08406061004421084060610044218406061004421

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

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
00840606191425Primus66580-0012026-09-30
00840606191432Primus66580-0022026-09-30
00840606191449Primus66581-0102026-09-30
00840606191456Primus66581-0122026-09-30
00840606191500Primus66623-0002026-09-30
00840606105927LOTUS32535-0102019-02-01
00840606105934LOTUS32535-0122019-02-01
00840606105941LOTUS32535-0142019-02-01
00840606105958LOTUS32535-0162019-01-28
00840606105965LOTUS32535-0182019-02-01
00840606105972LOTUS32535-0202019-01-28
00840606105989LOTUS32535-0222019-01-28
00840606105996LOTUS32535-0242019-02-01
00840606106009LOTUS32535-0262019-02-01
00840606106016LOTUS32535-0282019-02-01
00840606106023LOTUS32535-0302019-02-01
00840606106030LOTUS32535-0322019-02-01
00840606106047LOTUS32535-0342019-02-01
00840606106054LOTUS32535-0362019-02-01
00840606106061LOTUS32535-0382019-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157118389ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118396ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118402ZAVATION SCREWZavation LLCNKB2026-10-01
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00197157118426ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118433ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118440ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118457ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118464ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118471ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118488ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118495ZAVATION SCREWZavation LLCNKB2026-10-01
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00197157118563ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118570ZAVATION SCREWZavation LLCNKB2026-10-01