ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM 27-122

GUDID 00846468050801

One Level, Standard Plate, 22mm

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00846468050801
• NIH Device Record Key: 12ef22d7-45c0-4d5c-acc3-4e1311443c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM
• Version Model Number: 27-122
• Catalog Number: 27-122
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468050801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130427

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

[00846468050801]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-23

On-Brand Devices [ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM]

• 00846468051440: Four Level, Standard Plate, 80mm
• 00846468051433: Four Level, Standard Plate, 76mm
• 00846468051426: Four Level, Standard Plate, 72mm
• 00846468051419: Four Level, Standard Plate, 68mm
• 00846468051402: Four Level, Standard Plate, 64mm
• 00846468051396: Four Level, Standard Plate, 60mm
• 00846468051365: Ø4.5X16mm VAR SELF TAPPING RESCUE SCREW
• 00846468051358: Ø4.5X14mm VAR SELF TAPPING RESCUE SCREW
• 00846468051341: Ø4.5X12mm VAR SELF TAPPING RESCUE SCREW
• 00846468051303: Ø4.5X16mm FIXD SELF TAPPING RESCUE SCREW
• 00846468051297: Ø4.5X14mm FIXD SELF TAPPING RESCUE SCREW
• 00846468051280: Ø4.5X12mm FIXD SELF TAPPING RESCUE SCREW
• 00846468051259: Ø4.0 X 18mm VARIABLE SELF TAPPING SCREW
• 00846468051242: Ø4.0 X 16mm VARIABLE SELF TAPPING SCREW
• 00846468051235: Ø4.0 X 14mm VARIABLE SELF TAPPING SCREW
• 00846468051228: Ø4.0 X 12mm VARIABLE SELF TAPPING SCREW
• 00846468051181: Ø4.0 X 16mm VARIABLE SELF DRILLING SCREW
• 00846468051174: Ø4.0 X 14mm VARIABLE SELF DRILLING SCREW
• 00846468051167: Ø4.0 X 12mm VARIABLE SELF DRILLING SCREW
• 00846468051136: Ø4.0 X 18mm FIXED SELF TAPPING SCREW
• 00846468051129: Ø4.0 X 16mm FIXED SELF TAPPING SCREW
• 00846468051112: Ø4.0 X 14mm FIXED SELF TAPPING SCREW
• 00846468051105: Ø4.0 X 12mm FIXED SELF TAPPING SCREW
• 00846468051068: Ø4.0 X 16mm FIXED SELF DRILLING SCREW
• 00846468051051: Ø4.0 X 14mm FIXED SELF DRILLING SCREW
• 00846468051044: Ø4.0 X 12mm FIXED SELF DRILLING SCREW
• 00846468051006: Three Level, Standard Plate, 63mm
• 00846468050993: Three Level, Standard Plate, 60mm
• 00846468050986: Three Level, Standard Plate, 57mm
• 00846468050979: Three Level, Standard Plate, 54mm
• 00846468050962: Three Level, Standard Plate, 51mm
• 00846468050955: Three Level, Standard Plate, 48mm
• 00846468050948: Three Level, Standard Plate, 45mm
• 00846468050931: Three Level, Standard Plate, 42mm
• 00846468050917: Two Level, Standard Plate, 41mm
• 00846468050900: Two Level, Standard Plate, 38mm
• 00846468050894: Two Level, Standard Plate, 36mm
• 00846468050887: Two Level, Standard Plate, 34mm
• 00846468050870: Two Level, Standard Plate, 32mm
• 00846468050863: Two Level, Standard Plate, 30mm
• 00846468050856: Two Level, Standard Plate, 28mm
• 00846468050849: Two Level, Standard Plate, 26mm
• 00846468050818: One Level, Standard Plate, 24mm
• 00846468050801: One Level, Standard Plate, 22mm
• 00846468050795: One Level, Standard Plate, 20mm
• 00846468050788: One Level, Standard Plate, 18mm
• 00846468050771: One Level, Standard Plate, 16mm
• 00846468050764: One Level, Standard Plate, 14mm
• 00846468050757: One Level, Standard Plate, 12mm
• 00846468050740: One Level, Standard Plate, 10mm