3DP AIS-C II Cervical Interbody System ACC804-11L

GUDID M719ACC80411L0

11 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody

Genesys Orthopedics Systems LLC

Metallic spinal interbody fusion cage
Primary Device IDM719ACC80411L0
NIH Device Record Key2e177e35-7d2c-4658-bcbf-f37fcf387451
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DP AIS-C II Cervical Interbody System
Version Model Number1
Catalog NumberACC804-11L
Company DUNS017921066
Company NameGenesys Orthopedics Systems LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Dimensions

Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719ACC80411L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


[M719ACC80411L0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-12
Device Publish Date2024-03-04

On-Brand Devices [3DP AIS-C II Cervical Interbody System]

M719SEC80712L0Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80711S0Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80711L0Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80710S0Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80710L0Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80709S0Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80709L0Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80708S0Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80708L0Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80707S0Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80707L0Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80706S0Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
M719SEC80706L0Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
M719SEC80612S0Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80612L0Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80611S0Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80611L0Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80610S0Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80610L0Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80609S0Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80609L0Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80608S0Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80608L0Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80607S0Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80607L0Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80606S0Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80606L0Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80605S0Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
M719SEC80605L0Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
M719SEC80512S0Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80512L0Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80511S0Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80511L0Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80510S0Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80510L0Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80509S0Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80509L0Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80508S0Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80508L0Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80507S0Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80507L0Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80506S0Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80506L0Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80505S0Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
M719SEC80505L0Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
M719SEC80412S0Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody
M719SEC80412L0Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody
M719SEC80411S0Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody
M719SEC80411L0Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody
M719SEC80410S0Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody

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