Sapphire X3

GUDID 00840606176552

1-LEVEL SAPPHIRE X3, 16MM, 16.5MM WIDE

SPINAL ELEMENTS, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840606176552
• NIH Device Record Key: c09d1e72-fdc0-44aa-95e9-2452c8ffd913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire X3
• Version Model Number: 27071-016
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840606176552 [Primary]

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

[00840606176552]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Sapphire X3]

• 00840606181259: SAPPHIRE X 3-HOLE INSERTER,SHORT
• 00840606181310: SAPPHIRE X 3-HOLE INSERTER, HANDLE
• 00840606181303: SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY LONG
• 00840606181297: SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY MEDIUM
• 00840606181280: SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLYSHORT
• 00840606181273: SAPPHIRE X 3-HOLE INSERTER,LONG
• 00840606181266: SAPPHIRE X 3-HOLE INSERTER,MEDIUM
• 00840606178358: 1-LEVEL SAPPHIRE X3, 27MM, 17.5MM WIDE
• 00840606178341: 1-LEVEL SAPPHIRE X3, 26MM, 17.5MM WIDE
• 00840606178334: 1-LEVEL SAPPHIRE X3, 25MM, 17.5MM WIDE
• 00840606178327: 1-LEVEL SAPPHIRE X3, 24MM, 17.5MM WIDE
• 00840606178310: 1-LEVEL SAPPHIRE X3, 23MM, 17.5MM WIDE
• 00840606178303: 1-LEVEL SAPPHIRE X3, 22MM, 17.5MM WIDE
• 00840606178297: 1-LEVEL SAPPHIRE X3, 21MM, 17.5MM WIDE
• 00840606178280: 1-LEVEL SAPPHIRE X3, 20MM, 17.5MM WIDE
• 00840606178273: 1-LEVEL SAPPHIRE X3, 19MM, 17.5MM WIDE
• 00840606178266: 1-LEVEL SAPPHIRE X3, 18MM, 17.5MM WIDE
• 00840606178259: 1-LEVEL SAPPHIRE X3, 17MM, 17.5MM WIDE
• 00840606178242: 1-LEVEL SAPPHIRE X3, 16MM, 17.5MM WIDE
• 00840606178235: 1-LEVEL SAPPHIRE X3, 15MM, 17.5MM WIDE
• 00840606178228: 1-LEVEL SAPPHIRE X3, 14MM, 17.5MM WIDE
• 00840606178211: 1-LEVEL SAPPHIRE X3, 13MM, 17.5MM WIDE
• 00840606178204: 1-LEVEL SAPPHIRE X3, 12MM, 17.5MM WIDE
• 00840606178198: 1-LEVEL SAPPHIRE X3, 11MM, 17.5MM WIDE
• 00840606178181: 1-LEVEL SAPPHIRE X3, 10MM, 17.5MM WIDE
• 00840606178174: 1-LEVEL SAPPHIRE X3, 9MM, 17.5.MM WIDE
• 00840606178167: 1-LEVEL SAPPHIRE X3, 8MM, 17.5MM WIDE
• 00840606176668: 1-LEVEL SAPPHIRE X3, 27MM, 16.5MM WIDE
• 00840606176651: 1-LEVEL SAPPHIRE X3, 26MM, 16.5MM WIDE
• 00840606176644: 1-LEVEL SAPPHIRE X3, 25MM, 16.5MM WIDE
• 00840606176637: 1-LEVEL SAPPHIRE X3, 24MM, 16.5MM WIDE
• 00840606176620: 1-LEVEL SAPPHIRE X3, 23MM, 16.5MM WIDE
• 00840606176613: 1-LEVEL SAPPHIRE X3, 22MM, 16.5MM WIDE
• 00840606176606: 1-LEVEL SAPPHIRE X3, 21MM, 16.5MM WIDE
• 00840606176590: 1-LEVEL SAPPHIRE X3, 20MM, 16.5MM WIDE
• 00840606176583: 1-LEVEL SAPPHIRE X3, 19MM, 16.5MM WIDE
• 00840606176576: 1-LEVEL SAPPHIRE X3, 18MM, 16.5MM WIDE
• 00840606176569: 1-LEVEL SAPPHIRE X3, 17MM, 16.5MM WIDE
• 00840606176552: 1-LEVEL SAPPHIRE X3, 16MM, 16.5MM WIDE
• 00840606176545: 1-LEVEL SAPPHIRE X3, 15MM, 16.5MM WIDE
• 00840606176538: 1-LEVEL SAPPHIRE X3, 14MM, 16.5MM WIDE
• 00840606176521: 1-LEVEL SAPPHIRE X3, 13MM, 16.5MM WIDE
• 00840606176514: 1-LEVEL SAPPHIRE X3, 12MM, 16.5MM WIDE
• 00840606176507: 1-LEVEL SAPPHIRE X3, 11MM, 16.5MM WIDE
• 00840606176491: 1-LEVEL SAPPHIRE X3, 10MM, 16.5MM WIDE
• 00840606176484: 1-LEVEL SAPPHIRE X3, 9MM, 16.5.MM WIDE
• 00840606176477: 1-LEVEL SAPPHIRE X3, 8MM, 16.5MM WIDE
• 00840606176323: Ø3.5MM X 20MM SELF-DRILLING,FIXED ANGLE SCREW
• 00840606176316: Ø3.5MM X 19MM SELF-DRILLING,FIXED ANGLE SCREW
• 00840606176309: Ø3.5MM X 18MM SELF-DRILLING,FIXED ANGLE SCREW