Double Ended Rasp/Trial 12x15x7, 6° 522-81005

GUDID 00810017914791

Double Ended Rasp/Trial 12x15x7, 6°

ELEVATION SPINE, INC.

Spinal implant trial
Primary Device ID00810017914791
NIH Device Record Keyaba99921-6bd9-413b-ae90-c6289552602b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Ended Rasp/Trial 12x15x7, 6°
Version Model Number522-81005
Catalog Number522-81005
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810017914791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

[00810017914791]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-07
Device Publish Date2025-03-28

Devices Manufactured by ELEVATION SPINE, INC.

00810017914777 - Double Ended Rasp/Trial 12x15x5, 6°2025-04-07 Double Ended Rasp/Trial 12x15x5, 6°
00810017914784 - Double Ended Rasp/Trial 12x15x6, 6°2025-04-07 Double Ended Rasp/Trial 12x15x6, 6°
00810017914791 - Double Ended Rasp/Trial 12x15x7, 6°2025-04-07Double Ended Rasp/Trial 12x15x7, 6°
00810017914791 - Double Ended Rasp/Trial 12x15x7, 6°2025-04-07 Double Ended Rasp/Trial 12x15x7, 6°
00810017914807 - Double Ended Rasp/Trial 12x15x8, 6°2025-04-07 Double Ended Rasp/Trial 12x15x8, 6°
00810017914814 - Double Ended Rasp/Trial 12x15x9, 6°2025-04-07 Double Ended Rasp/Trial 12x15x9, 6°
00810017914821 - Double Ended Rasp/Trial 14x17x5, 6°2025-04-07 Double Ended Rasp/Trial 14x17x5, 6°
00810017914838 - Double Ended Rasp/Trial 14x17x6, 6°2025-04-07 Double Ended Rasp/Trial 14x17x6, 6°
00810017914845 - Double Ended Rasp/Trial 14x17x7, 6°2025-04-07 Double Ended Rasp/Trial 14x17x7, 6°
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