Inspire Lumbar Interbody Fusion System

GUDID B648C43428090881

Porous PEEK TLIF Spacer, 28 x 9 x 8mm, 8 deg

CURITEVA, INC.

Polymeric spinal interbody fusion cage
Primary Device IDB648C43428090881
NIH Device Record Key36010513-9523-406b-97fe-e9e088158e9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspire Lumbar Interbody Fusion System
Version Model NumberC434-280908-8
Company DUNS074575332
Company NameCURITEVA, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com

Device Dimensions

Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree
Width9 Millimeter
Height8 Millimeter
Length28 Millimeter
Angle8 degree

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB648C43428090881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [Inspire Lumbar Interbody Fusion System]

B648C43428091381Porous PEEK TLIF Spacer, 28 x 9 x 13mm, 8 deg
B648C43428091281Porous PEEK TLIF Spacer, 28 x 9 x 12mm, 8 deg
B648C43428091181Porous PEEK TLIF Spacer, 28 x 9 x 11mm, 8 deg
B648C43428091081Porous PEEK TLIF Spacer, 28 x 9 x 10mm, 8 deg
B648C43428090981Porous PEEK TLIF Spacer, 28 x 9 x 9mm, 8 deg
B648C43428090881Porous PEEK TLIF Spacer, 28 x 9 x 8mm, 8 deg
B648C43428090781Porous PEEK TLIF Spacer, 28 x 9 x 7mm, 8 deg
B648C33426091201Porous PEEK PLIF Spacer, 26 x 9 x 12mm, 0 deg
B648C33426091101Porous PEEK PLIF Spacer, 26 x 9 x 11mm, 0 deg
B648C33426091001Porous PEEK PLIF Spacer, 26 x 9 x 10mm, 0 deg
B648C33426090901Porous PEEK PLIF Spacer, 26 x 9 x 9mm, 0 deg
B648C33426090801Porous PEEK PLIF Spacer, 26 x 9 x 8mm, 0 deg
B648C33426090701Porous PEEK PLIF Spacer, 26 x 9 x 7mm, 0 deg
B648C33426090601Porous PEEK PLIF Spacer, 26 x 9 x 6mm, 0 deg
B648C33422091201Porous PEEK PLIF Spacer, 22 x 9 x 12mm, 0 deg
B648C33422091101Porous PEEK PLIF Spacer, 22 x 9 x 11mm, 0 deg
B648C33422091001Porous PEEK PLIF Spacer, 22 x 9 x 10mm, 0 deg
B648C33422090901Porous PEEK PLIF Spacer, 22 x 9 x 9mm, 0 deg
B648C33422090801Porous PEEK PLIF Spacer, 22 x 9 x 8mm, 0 deg
B648C33422090701Porous PEEK PLIF Spacer, 22 x 9 x 7mm, 0 deg
B648C33422090601Porous PEEK PLIF Spacer 22 x 09 x 06mm, 0deg
B648C2844028186140 (W) x 28 (D) x 18mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28440281812140 (W) x 28 (D) x 18mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2844028166140 (W) x 28 (D) x 16mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28440281612140 (W) x 28 (D) x 16mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2844028146140 (W) x 28 (D) x 14mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28440281412140 (W) x 28 (D) x 14mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2844028126140 (W) x 28 (D) x 12mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28440281212140 (W) x 28 (D) x 12mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2844028106140 (W) x 28 (D) x 10mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28440281012140 (W) x 28 (D) x 10mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526186135 (W) x 26 (D) x 18mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28435261812135 (W) x 26 (D) x 18mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526166135 (W) x 26 (D) x 16mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28435261612135 (W) x 26 (D) x 16mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526146135 (W) x 26 (D) x 14mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28435261412135 (W) x 26 (D) x 14mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526126135 (W) x 26 (D) x 12mm (H) x 6° (A) Porous PEEK ALIF Cage
B648C28435261212135 (W) x 26 (D) x 12mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526106135 (W) x 26 (D) x 10mm (H) x 6° (A) Porous PEEK ALIF Cag
B648C28435261012135 (W) x 26 (D) x 10mm (H) x 12° (A) Porous PEEK ALIF Cage
B648C2843526086135 (W) x 26 (D) x 08mm (H) x 6° (A) Porous PEEK ALIF Cage

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