Sapphire X3

GUDID 00840606178235

1-LEVEL SAPPHIRE X3, 15MM, 17.5MM WIDE

SPINAL ELEMENTS, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00840606178235
NIH Device Record Key537e0cee-c6a5-45ab-b20e-1ac8a26df93f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire X3
Version Model Number27081-015
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606178235 [Primary]

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


[00840606178235]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-02

On-Brand Devices [Sapphire X3]

00840606181259SAPPHIRE X 3-HOLE INSERTER,SHORT
00840606181310SAPPHIRE X 3-HOLE INSERTER, HANDLE
00840606181303SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY LONG
00840606181297SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY MEDIUM
00840606181280SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLYSHORT
00840606181273SAPPHIRE X 3-HOLE INSERTER,LONG
00840606181266SAPPHIRE X 3-HOLE INSERTER,MEDIUM
008406061783581-LEVEL SAPPHIRE X3, 27MM, 17.5MM WIDE
008406061783411-LEVEL SAPPHIRE X3, 26MM, 17.5MM WIDE
008406061783341-LEVEL SAPPHIRE X3, 25MM, 17.5MM WIDE
008406061783271-LEVEL SAPPHIRE X3, 24MM, 17.5MM WIDE
008406061783101-LEVEL SAPPHIRE X3, 23MM, 17.5MM WIDE
008406061783031-LEVEL SAPPHIRE X3, 22MM, 17.5MM WIDE
008406061782971-LEVEL SAPPHIRE X3, 21MM, 17.5MM WIDE
008406061782801-LEVEL SAPPHIRE X3, 20MM, 17.5MM WIDE
008406061782731-LEVEL SAPPHIRE X3, 19MM, 17.5MM WIDE
008406061782661-LEVEL SAPPHIRE X3, 18MM, 17.5MM WIDE
008406061782591-LEVEL SAPPHIRE X3, 17MM, 17.5MM WIDE
008406061782421-LEVEL SAPPHIRE X3, 16MM, 17.5MM WIDE
008406061782351-LEVEL SAPPHIRE X3, 15MM, 17.5MM WIDE
008406061782281-LEVEL SAPPHIRE X3, 14MM, 17.5MM WIDE
008406061782111-LEVEL SAPPHIRE X3, 13MM, 17.5MM WIDE
008406061782041-LEVEL SAPPHIRE X3, 12MM, 17.5MM WIDE
008406061781981-LEVEL SAPPHIRE X3, 11MM, 17.5MM WIDE
008406061781811-LEVEL SAPPHIRE X3, 10MM, 17.5MM WIDE
008406061781741-LEVEL SAPPHIRE X3, 9MM, 17.5.MM WIDE
008406061781671-LEVEL SAPPHIRE X3, 8MM, 17.5MM WIDE
008406061766681-LEVEL SAPPHIRE X3, 27MM, 16.5MM WIDE
008406061766511-LEVEL SAPPHIRE X3, 26MM, 16.5MM WIDE
008406061766441-LEVEL SAPPHIRE X3, 25MM, 16.5MM WIDE
008406061766371-LEVEL SAPPHIRE X3, 24MM, 16.5MM WIDE
008406061766201-LEVEL SAPPHIRE X3, 23MM, 16.5MM WIDE
008406061766131-LEVEL SAPPHIRE X3, 22MM, 16.5MM WIDE
008406061766061-LEVEL SAPPHIRE X3, 21MM, 16.5MM WIDE
008406061765901-LEVEL SAPPHIRE X3, 20MM, 16.5MM WIDE
008406061765831-LEVEL SAPPHIRE X3, 19MM, 16.5MM WIDE
008406061765761-LEVEL SAPPHIRE X3, 18MM, 16.5MM WIDE
008406061765691-LEVEL SAPPHIRE X3, 17MM, 16.5MM WIDE
008406061765521-LEVEL SAPPHIRE X3, 16MM, 16.5MM WIDE
008406061765451-LEVEL SAPPHIRE X3, 15MM, 16.5MM WIDE
008406061765381-LEVEL SAPPHIRE X3, 14MM, 16.5MM WIDE
008406061765211-LEVEL SAPPHIRE X3, 13MM, 16.5MM WIDE
008406061765141-LEVEL SAPPHIRE X3, 12MM, 16.5MM WIDE
008406061765071-LEVEL SAPPHIRE X3, 11MM, 16.5MM WIDE
008406061764911-LEVEL SAPPHIRE X3, 10MM, 16.5MM WIDE
008406061764841-LEVEL SAPPHIRE X3, 9MM, 16.5.MM WIDE
008406061764771-LEVEL SAPPHIRE X3, 8MM, 16.5MM WIDE
00840606176323Ø3.5MM X 20MM SELF-DRILLING,FIXED ANGLE SCREW
00840606176316Ø3.5MM X 19MM SELF-DRILLING,FIXED ANGLE SCREW
00840606176309Ø3.5MM X 18MM SELF-DRILLING,FIXED ANGLE SCREW

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