ORIO-Ti Cage System A7L30-18-Ti

GUDID 00193082120961

ORIO-Ti - ALIF Cage, Large 25 x 33 x 18mm, 30 deg.

SPINECRAFT, LLC

Metallic spinal interbody fusion cage
Primary Device ID00193082120961
NIH Device Record Keydc507e0a-fc6e-47ce-8e83-f0917ca2634e
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIO-Ti Cage System
Version Model NumberA7L30-18-Ti
Catalog NumberA7L30-18-Ti
Company DUNS783908713
Company NameSPINECRAFT, LLC
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193082120961 [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

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

[00193082120961]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

On-Brand Devices [ORIO-Ti Cage System]

00193082121227ORIO-Ti - ALIF Cage, Large 25 x 33 x 10mm, 0 deg.
00193082155109ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 14 x 24mm
00193082155093ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 15 x 26mm
00193082155086ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 13 x 26mm
00193082155079ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 13 x 22mm
00193082155062ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 11 x 24mm
00193082155055ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 8 x 26mm
00193082155048ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 14 x 26mm
00193082155031ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 12 x 24mm
00193082155024ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 13 x 24mm
00193082155017ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 11 x 26mm
00193082155000ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 11 x 26mm
00193082154997ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 12 x 24mm
00193082154980ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 11 x 24mm
00193082154973ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 12 x 26mm
00193082154966ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 13 x 24mm
00193082154959ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 8 x 24mm
00193082154942ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 9 x 24mm
00193082154935ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 15 x 24mm
00193082154928ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 10 x 26mm
00193082154911ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 13 x 26mm
00193082154904ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 8 x 22mm
00193082154898ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 12 x 26mm
00193082154881ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 14 x 22mm
00193082154874ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 12 x 22mm
00193082154867ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 10 x 24mm
00193082154850ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 15 x 22mm
00193082154843ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 9 x 26mm
00193082153334ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 11 x 22mm
00193082153327ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 10 x 22mm
00193082153310ORIO-Ti - P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 9 x 22mm
00193082153303ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 10 x 26mm
00193082153297ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 10 x 24mm
00193082153280ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 9 x 26mm
00193082153273ORIO-Ti - Trapezoidal P-TLIF Cage 9mm Wide, 5 deg. Lordosis, 9 x 24mm
00193082121210ORIO-Ti - ALIF Cage, Small 23 x 31 x 20mm, 30 deg.
00193082121203ORIO-Ti - ALIF Cage, Small 23 x 31 x 18mm, 30 deg.
00193082121197ORIO-Ti - ALIF Cage, Small 23 x 31 x 16mm, 30 deg.
00193082121180ORIO-Ti - ALIF Cage, Small 23 x 31 x 20mm, 22.5 deg.
00193082121173ORIO-Ti - ALIF Cage, Small 23 x 31 x 18mm, 22.5 deg.
00193082121166ORIO-Ti - ALIF Cage, Small 23 x 31 x 16mm, 22.5 deg.
00193082121159ORIO-Ti - ALIF Cage, Small 23 x 31 x 20mm, 15 deg.
00193082121142ORIO-Ti - ALIF Cage, Small 23 x 31 x 18mm, 15 deg.
00193082121135ORIO-Ti - ALIF Cage, Small 23 x 31 x 16mm, 15 deg.
00193082121128ORIO-Ti - ALIF Cage, Small 23 x 31 x 14mm, 15 deg.
00193082121111ORIO-Ti - ALIF Cage, Small 23 x 31 x 12mm, 15 deg.
00193082121104ORIO-Ti - ALIF Cage, Small 23 x 31 x 10mm, 15 deg.
00193082121098ORIO-Ti - ALIF Cage, Small 23 x 31 x 20mm, 7.5 deg.
00193082121081ORIO-Ti - ALIF Cage, Small 23 x 31 x 18mm, 7.5 deg.
00193082121074ORIO-Ti - ALIF Cage, Small 23 x 31 x 16mm, 7.5 deg.
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