"12(w) x 15(d) Saber-C Bodies (PEEK) " CBP-2508

GUDID 00810017910151

Saber-C Body (P), 12x15x8 0 deg.

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system
Primary Device ID00810017910151
NIH Device Record Key9045b970-49b5-419f-a758-1b90c8124a08
Commercial Distribution StatusIn Commercial Distribution
Brand Name"12(w) x 15(d) Saber-C Bodies (PEEK) "
Version Model NumberCBP-2508
Catalog NumberCBP-2508
Company DUNS085718404
Company NameELEVATION SPINE, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810017910151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-13
Device Publish Date2019-12-05

On-Brand Devices ["12(w) x 15(d) Saber-C Bodies (PEEK) "]

00810017910229Saber-C Body (P), 12x15x9 6 deg.
00810017910212Saber-C Body (P), 12x15x8 6 deg.
00810017910205Saber-C Body (P), 12x15x7 6 deg.
00810017910199Saber-C Body (P), 12x15x6 6 deg.
00810017910182Saber-C Body (P), 12x15x5 6 deg.
00810017910175Saber-C Body (P), 12x15x10 0 deg.
00810017910168Saber-C Body (P), 12x15x9 0 deg.
00810017910151Saber-C Body (P), 12x15x8 0 deg.
00810017910144Saber-C Body (P), 12x15x7 0 deg.
00810017910137Saber-C Body (P), 12x15x6 0 deg.
00810017910120Saber-C Body (P), 12x15x5 0 deg.
00810017910298Saber-C Body (P), 12x15x10 9 deg.
00810017910281Saber-C Body (P), 12x15x9 9 deg.
00810017910274Saber-C Body (P), 12x15x8 9 deg.
00810017910267Saber-C Body (P), 12x15x7 9 deg.
00810017910250Saber-C Body (P), 12x15x6 9 deg.
00810017910243Saber-C Body (P), 12x15x5 9 deg.
00810017910236Saber-C Body (P), 12x15x10 6 deg.
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.