Dual X Graft Tamp

Primary DI
B70712535005A0
Brand
Dual X Graft Tamp
Company
AMPLIFY SURGICAL, INC.
Model
12535005A0
Device description
Dual X Graft Tamp
Published
2019-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181397000DualXInnovasive, Inc.2018-09-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B70712535005A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tampA hand-held, surgical instrument used to pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of high-grade stainless steel, but some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
949-220-1286admin@innovasiveinc.com

Regulatory Flags#

DUNS number
081021000
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7070800118US0DUALX DUAL PORTAL MICRO PITUITARY STRAIGHT 2.0mm0800118US2026-09-28
B7070800218US0DUALX DUAL PORTAL MICRO PITUITARY UP 2.0mm0800218US2026-09-28
B707602003US0DUALX DUAL PORTAL PITUITARY STRAIGHT 2.0mm602003US2026-09-28
B707BHP18042US0DUALX DUAL PORTAL BALL HOOKBHP18042US2026-09-28
B707QU332130US0DUALX DUAL PORTAL CURETTE UP 3.0mmQU332130US2026-09-28
B707UNH2002US0DUALX DUAL PORTAL ROTATORY HANDLEUNH2002US2026-09-28
B707UNH4020US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mmUNH4020US2026-09-28
B707UNH4030US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 3.0mmUNH4030US2026-09-28
B707USCH2US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR CLAMPUSCH2US2026-09-28
B707USCH3US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR FUSIONUSCH3US2026-09-28
B707USCH1US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR GENERALUSCH1US2025-05-29
B707125355730300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)125355730302026-09-04
B707125355730400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)125355730402026-09-04
B707125355730500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)125355730502026-09-04
B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)125355730602026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)125355730702026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)125355730802026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)125355730902026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)125355731002026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)125355731102026-09-04

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