PERIMETER™ System

GUDID 00643169167773

SPACER X1111489 PERIMETER LG 8DEG 9MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169167773
• NIH Device Record Key: 8d3a1af8-810c-4cd6-8e52-dc4e7e2d9c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER™ System
• Version Model Number: X1111489
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169167773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090353

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-07-01

On-Brand Devices [PERIMETER™ System]

• 00643169190054: TRIAL X1111510 PERIMETER SML 4 DEG X 9
• 00643169190047: TRIAL X1111511 PERIMETER SML 4 DEG X 11
• 00643169190030: TRIAL X1111512 PERIMETER SML 4 DEG X 13
• 00643169190023: TRIAL X1111513 PERIMETER SML 4 DEG X 15
• 00643169190016: TRIAL X1111514 PERIMETER SML 4 DEG X 17
• 00643169190009: TRIAL X1111515 PERIMETER SML 4 DEG X 19
• 00643169189997: TRIAL X1111516 PERIMETER MED 8 DEG X 9
• 00643169189980: TRIAL X1111517 PERIMETER MED 8 DEG X 11
• 00643169189973: TRIAL X1111518 PERIMETER MED 8 DEG X 13
• 00643169189966: TRIAL X1111519 PERIMETER MED 8 DEG X 15
• 00643169189959: TRIAL X1111520 PERIMETER MED 8 DEG X 17
• 00643169189942: TRIAL X1111521 PERIMETER MED 8 DEG X 19
• 00643169189935: TRIAL X1111522 PERIMETER LRG 8 DEG X 9
• 00643169189928: TRIAL X1111523 PERIMETER LRG 8 DEG X 11
• 00643169189911: TRIAL X1111524 PERIMETER LRG 8 DEG X 13
• 00643169189904: TRIAL X1111525 PERIMETER LRG 8 DEG X 15
• 00643169189898: TRIAL X1111526 PERIMETER LRG 8 DEG X 17
• 00643169189881: TRIAL X1111527 PERIMETER LRG 8 DEG X 19
• 00643169189874: TRIAL X1111528 PERIMETER LRG 12 DEG X 11
• 00643169189867: TRIAL X1111529 PERIMETER LRG 12 DEG X 13
• 00643169189850: TRIAL X1111530 PERIMETER LRG 12 DEG X 15
• 00643169189843: TRIAL X1111531 PERIMETER LRG 12 DEG X 17
• 00643169189836: TRIAL X1111532 PERIMETER LRG 12 DEG X 19
• 00643169189829: TRIAL X1111538 PERIMETER XL 8 DEG X 9
• 00643169189812: TRIAL X1111539 PERIMETER XL 8 DEG X 11
• 00643169189805: TRIAL X1111540 PERIMETER XL 8 DEG X 13
• 00643169189799: TRIAL X1111541 PERIMETER XL 8 DEG X 15
• 00643169189782: TRIAL X1111542 PERIMETER XL 8 DEG X 17
• 00643169189775: TRIAL X1111543 PERIMETER XL 8 DEG X 19
• 00643169167780: SPACER X1111490 PERIMETER LG 8DEG 11MM
• 00643169167773: SPACER X1111489 PERIMETER LG 8DEG 9MM
• 00643169167766: SPACER X1111488 PERIMETER MD 8DEG 19MM
• 00643169167759: SPACER X1111487 PERIMETER MD 8DEG 17MM
• 00643169167742: SPACER X1111486 PERIMETER MD 8DEG 15MM
• 00643169167735: SPACER X1111485 PERIMETER MD 8DEG 13MM
• 00643169167728: SPACER X1111484 PERIMETER MD 8DEG 11MM
• 00643169167711: SPACER X1111483 PERIMETER MD 8DEG 9MM
• 00643169167704: SPACER X1111482 PERIMETER SM 4DEG 19MM
• 00643169167698: SPACER X1111481 PERIMETER SM 4DEG 17MM
• 00643169167681: SPACER X1111480 PERIMETER SM 4DEG 15MM
• 00643169167674: SPACER X1111479 PERIMETER SM 4DEG 13MM
• 00643169167667: SPACER X1111478 PERIMETER SM 4DEG 11MM