FDA.report

Mercury

Primary DI
00840606100830
Brand
Mercury
Company
SPINAL ELEMENTS, INC.
Model
63465-060
Device description
6.5mm x 60mm Iliac Polyaxial Screw
Published
2019-03-05
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

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840606100830PrimaryGS10

GMDN Terms

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
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

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00840606187145Primus66900-000-012026-02-27
00840606187152Primus66900-000-022026-02-27
00840606187169Primus66900-000-032026-02-27
00840606187176Primus66900-000-042026-02-27
00840606187268Primus66900-0302026-02-27
00840606187275Primus66900-030-012026-02-27
00840606187282Primus66900-030-022026-02-27
00840606187299Primus66900-030-032026-02-27
00840606187305Primus66900-030-042026-02-27
00840606187312Primus66900-030-052026-02-27
00840606187329Primus66900-030-062026-02-27
00840606187336Primus66900-030-072026-02-27
00840606187343Primus66900-030-082026-02-27
00840606187367Primus66900-030-092026-02-27
00840606185172Primus66430-0182026-01-23
00840606185189Primus66430-0242026-01-23
00840606185196Primus66430-1182026-01-23
00840606185202Primus66430-1242026-01-23

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00840493418704RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418711RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418728RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418735RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418742RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418759RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418766RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418773RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418780RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418797RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418803RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418810RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418827RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418834RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418841RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418858RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418865RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418872RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418889RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418896RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418902RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418919RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418926RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418933RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418940RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418957RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418964RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418971RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00190837124458ArxLife Spine, Inc.NKB2026-03-23
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