PERIMETER Spinal System

GUDID 00643169584976

SPACER X1214433 PER TI STER XL 12D 36X14

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00643169584976
• NIH Device Record Key: a9257177-cef7-40ca-8f61-3acc69ac06d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER Spinal System
• Version Model Number: X1214433
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169584976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160418

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: 2017-08-17

On-Brand Devices [PERIMETER Spinal System]

• 00643169585065: SPACER X1214442 PER TI STER XXL 15 38X18
• 00643169585058: SPACER X1214441 PER TI STER XXL 15 38X16
• 00643169585041: SPACER X1214440 PER TI STER XXL 15 38X14
• 00643169585034: SPACER X1214439 PER TI STER XXL 15 38X12
• 00643169585027: SPACER X1214438 PER TI STER XXL 15 38X10
• 00643169585010: SPACER X1214437 PER TI STER XXL 15D 38X8
• 00643169585003: SPACER X1214436 PER TI STER XL 12D 36X20
• 00643169584990: SPACER X1214435 PER TI STER XL 12D 36X18
• 00643169584983: SPACER X1214434 PER TI STER XL 12D 36X16
• 00643169584976: SPACER X1214433 PER TI STER XL 12D 36X14
• 00643169584969: SPACER X1214432 PER TI STER XL 12D 36X12
• 00643169584952: SPACER X1214431 PER TI STER XL 12D 36X10
• 00643169584938: SPACER X1214429 PER TI STER XL 8D 36X20
• 00643169584921: SPACER X1214428 PER TI STER XL 8D 36X18
• 00643169584914: SPACER X1214427 PER TI STER XL 8D 36X16
• 00643169584907: SPACER X1214426 PER TI STER XL 8D 36X14
• 00643169584891: SPACER X1214425 PER TI STER XL 8D 36X12
• 00643169584884: SPACER X1214424 PER TI STER XL 8D 36X10
• 00643169584860: SPACER X1214422 PER TI STER LG 12D 30X20
• 00643169584853: SPACER X1214421 PER TI STER LG 12D 30X18
• 00643169584846: SPACER X1214420 PER TI STER LG 12D 30X16
• 00643169584839: SPACER X1214419 PER TI STER LG 12D 30X14
• 00643169584822: SPACER X1214418 PER TI STER LG 12D 30X12
• 00643169584815: SPACER X1214417 PER TI STER LG 12D 30X10
• 00643169584792: SPACER X1214415 PER TI STER LG 8D 30X20
• 00643169584785: SPACER X1214414 PER TI STER LG 8D 30X18
• 00643169584778: SPACER X1214413 PER TI STER LG 8D 30X16
• 00643169584761: SPACER X1214412 PER TI STER LG 8D 30X14
• 00643169584754: SPACER X1214411 PER TI STER LG 8D 30X12
• 00643169584747: SPACER X1214410 PER TI STER LG 8D 30X10
• 00643169584723: SPACER X1214408 PER TI STER MD 8D 26X20
• 00643169584716: SPACER X1214407 PER TI STER MD 8D 26X18
• 00643169584709: SPACER X1214406 PER TI STER MD 8D 26X16
• 00643169584693: SPACER X1214405 PER TI STER MD 8D 26X14
• 00643169584686: SPACER X1214404 PER TI STER MD 8D 26X12
• 00643169584679: SPACER X1214403 PER TI STER MD 8D 26X10
• 00643169584082: TRIAL X1214497 PER XXL 15DEG 20MM
• 00643169584075: TRIAL X1214496 PER XXL 15DEG 18MM
• 00643169584068: TRIAL X1214495 PER XXL 15DEG 16MM
• 00643169584051: TRIAL X1214494 PER XXL 15DEG 14MM
• 00643169584044: TRIAL X1214493 PER XXL 15DEG 12MM
• 00643169584037: TRIAL X1214492 PER XXL 15DEG 10MM
• 00643169584020: TRIAL X1214491 PER XL 12DEG 20MM
• 00643169584013: TRIAL X1214490 PER XL 12DEG 18MM
• 00643169584006: TRIAL X1214489 PER XL 12DEG 16MM
• 00643169583993: TRIAL X1214488 PER XL 12DEG 14MM
• 00643169583986: TRIAL X1214487 PER XL 12DEG 12MM
• 00643169583979: TRIAL X1214486 PER XL 12DEG 10MM
• 00643169583955: TRIAL X1214484 PER XL 8DEG 20MM
• 00643169583948: TRIAL X1214483 PER XL 8DEG 18MM