FORZA XP

GUDID 18257200122585

10.5MM X 10MM WIDE X 28MM NON-LORDOTIC ASSEMBLY

ORTHOFIX INC.

Metallic spinal interbody fusion cage

Primary Device ID	18257200122585
NIH Device Record Key	762be484-c193-4f36-afb0-c880f5f576a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	FORZA XP
Version Model Number	28-2184
Company DUNS	927083808
Company Name	ORTHOFIX 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	false
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)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com
Phone	+1(800)527-0404
Email	customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200122585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172696

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

[18257200122585]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-02-24
Device Publish Date	2019-03-19

On-Brand Devices [FORZA XP]

18257200142613	FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9092)
18257200142163	FUNNEL PLUNGER
18257200140930	FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9091)
18257200135479	IMPLANT INSERTER ASSEMBLY
18257200131433	IMPLANT REMOVER DRIVER
18257200131402	IMPLANT REMOVER
18257200130672	FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9091)
18257200130665	FORZA XP - IMPLANT CADDY, IMPLANT/INSTRUMENT CASE
18257200130658	FORZA XP - BOTTOM TRAY-LEVEL, IMPLANT/INSTRUMENT CASE
18257200130641	FORZA XP - TOP TRAY-LEVEL, IMPLANT/INSTRUMENT CASE
18257200130634	FORZA XP - BASE, IMPLANT/INSTRUMENT CASE
18257200130627	FORZA XP - IMPLANT/INSTRUMENT CASE
18257200130573	TORQUE LIMITING HANDLE
18257200130566	AXIAL TORQUE LIMITING HANDLE
18257200126323	IMPLANT DRIVER
18257200126316	SLAP HAMMER ASSEMBLY
18257200126309	FUNNEL
18257200126293	FUNNEL PLUNGER
18257200126286	12.5 H x 10 W TRIAL
18257200126279	10.5 H x 10 W TRIAL
18257200126262	8.5 H x 10 W TRIAL
18257200126255	6.5 H x 10 W TRIAL
18257200126248	IMPLANT STABILIZER ASSEMBLY
18257200126231	IMPLANT INSERTER ASSEMBLY
18257200123131	12.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123124	10.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123117	8.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123100	12.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123094	10.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123087	8.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123070	12.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123063	10.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123056	8.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY
18257200123049	12.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123032	10.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123025	8.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY
18257200123001	12.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122981	10.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122967	8.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122943	12.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122929	10.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122905	8.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122882	12.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122868	10.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122844	8.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122820	12.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122806	10.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122783	8.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY
18257200122776	6.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY
18257200122769	6.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY

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