BIOFOAM

GUDID 00840420143242

WRIGHT MEDICAL TECHNOLOGY, INC.

Metallic osteotomy fusion cage, sterile Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840420143242
• NIH Device Record Key: 5eb18ad1-b414-412d-9b89-4d8d4e065357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFOAM
• Version Model Number: 46S52208
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL 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: true
• 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(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420143242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070592

FDA Product Code

• HWC: Screw, fixation, bone

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: 2018-11-08
• Device Publish Date: 2015-10-01

On-Brand Devices [BIOFOAM]

• 00889797014946: 46081000
• 00840420172051: 47S02065
• 00840420172044: 47S02055
• 00840420172037: 47S02045
• 00840420172020: 47S01665
• 00840420172013: 47S01655
• 00840420172006: 47S01645
• 00840420171993: 47S52212
• 00840420171986: 47S52210
• 00840420171979: 47S52208
• 00840420171962: 47S52012
• 00840420171955: 47S52010
• 00840420171948: 47S52008
• 00840420171931: 47S51812
• 00840420171924: 47S51810
• 00840420171917: 47S51808
• 00840420171900: 47S01312
• 00840420171894: 47S01309
• 00840420171887: 47S01306
• 00840420171870: 47S02095
• 00840420171863: 47S02085
• 00840420171856: 47S02075
• 00840420165992: 46S01312
• 00840420165985: 46S01309
• 00840420163226: 46S01525
• 00840420163219: 46S01520
• 00840420163202: 46S01515
• 00840420163196: 46S01310
• 00840420163189: 46S01308
• 00840420163172: 46S01306
• 00840420163165: 46S02095
• 00840420163158: 46S02085
• 00840420163141: 46S02075
• 00840420148919: 46S02065
• 00840420148902: 46S02055
• 00840420148896: 46S02045
• 00840420148889: 46S01665
• 00840420148872: 46S01655
• 00840420148865: 46S01645
• 00840420143266: 46S52212
• 00840420143259: 46S52210
• 00840420143242: 46S52208
• 00840420143235: 46S52012
• 00840420143228: 46S52010
• 00840420143211: 46S52008
• 00840420143204: 46S51812
• 00840420143198: 46S51810
• 00840420143181: 46S51808
• 00840420135704: 46S42012
• 00840420135698: 46S42010