DUALX DUAL PORTAL SPADE KNIFE

GUDID B707K055S0

SPADE KNIFE

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707K055S0
NIH Device Record Key7ca0e72c-77e1-471b-886f-4c392aeef3fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX DUAL PORTAL SPADE KNIFE
Version Model NumberK055S
Company DUNS081021000
Company NameAmplify Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707K055S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


[B707K055S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

On-Brand Devices [DUALX DUAL PORTAL SPADE KNIFE]

B707TD1500SPADE KNIFE
B707K055S0SPADE KNIFE

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