FDA.reportPublic FDA data

Apollo Anterior Cervical Plate System

Primary DI
B521115002380
Brand
Apollo Anterior Cervical Plate System
Company
AURORA SPINE, INC.
Model
115-002-38
Device description
Apollo Plate 2 Level 38mm
Published
2024-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210325000APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.2021-03-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B521115002380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-424-2004info@auroraspine.us

Regulatory Flags#

DUNS number
079119091
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B521115001100Apollo Anterior Cervical Plate System115-001-102024-08-13
B521115001120Apollo Anterior Cervical Plate System115-001-122024-08-13
B521115001140Apollo Anterior Cervical Plate System115-001-142024-08-13
B521115001160Apollo Anterior Cervical Plate System115-001-162024-08-13
B521115001180Apollo Anterior Cervical Plate System115-001-182024-08-13
B521115001200Apollo Anterior Cervical Plate System115-001-202024-08-13
B521115001220Apollo Anterior Cervical Plate System115-001-222024-08-13
B521115001240Apollo Anterior Cervical Plate System115-001-242024-08-13
B521115001260Apollo Anterior Cervical Plate System115-001-262024-08-13
B521115002260Apollo Anterior Cervical Plate System115-002-262024-08-13
B521115002280Apollo Anterior Cervical Plate System115-002-282024-08-13
B521115002300Apollo Anterior Cervical Plate System115-002-302024-08-13
B521115002320Apollo Anterior Cervical Plate System115-002-322024-08-13
B521115002340Apollo Anterior Cervical Plate System115-002-342024-08-13
B521115002360Apollo Anterior Cervical Plate System115-002-362024-08-13
B521115002400Apollo Anterior Cervical Plate System115-002-402024-08-13
B521115002420Apollo Anterior Cervical Plate System115-002-422024-08-13
B521115003390Apollo Anterior Cervical Plate System115-003-392024-08-13
B521115003420Apollo Anterior Cervical Plate System115-003-422024-08-13
B521115003450Apollo Anterior Cervical Plate System115-003-452024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248452Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248513Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02