FDA.reportPublic FDA data

Cornice

Primary DI
B638CN1210P06100
Brand
Cornice
Company
LEGEND SPINE LLC
Model
CN1210P0610
Catalog number
CN1210P0610
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192208000CORNICE Cervical Spacer SystemLegend Spine Technologies2019-10-09ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B638CN1210P06100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
027460152
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B638CN1714P06040CorniceCN1714P0604CN1714P06042020-10-16
B638CN1714P06050CorniceCN1714P0605CN1714P06052020-10-16
B638CN1714P06060CorniceCN1714P0606CN1714P06062020-10-16
B638CN1714P06070CorniceCN1714P0607CN1714P06072020-10-16
B638CN1714P06080CorniceCN1714P0608CN1714P06082020-10-16
B638CN1714P06090CorniceCN1714P0609CN1714P06092020-10-16
B638CN1714P06100CorniceCN1714P0610CN1714P06102020-10-16
B638CN1714P06110CorniceCN1714P0611CN1714P06112020-10-16
B638CN1714P06120CorniceCN1714P0612CN1714P06122020-10-16
B638STT2209P05070STYLOSTT2209P0507STT2209P05072020-08-31
B638STT2209P05080STYLOSTT2209P0508STT2209P05082020-08-31
B638STT2209P05090STYLOSTT2209P0509STT2209P05092020-08-31
B638STT2209P05100STYLOSTT2209P0510STT2209P05102020-08-31
B638STT2209P05110STYLOSTT2209P0511STT2209P05112020-08-31
B638STT2209P05120STYLOSTT2209P0512STT2209P05122020-08-31
B638STT2209P05130STYLOSTT2209P0513STT2209P05132020-08-31
B638STT2209P05140STYLOSTT2209P0514STT2209P05142020-08-31
B638STT2209P05150STYLOSTT2209P0515STT2209P05152020-08-31
B638STT2409P05070STYLOSTT2409P0507STT2409P05072020-08-31
B638STT2409P05080STYLOSTT2409P0508STT2409P05082020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
07613327353945Aero-CStryker CorporationODP2018-06-28
07613327353952Aero-CStryker CorporationODP2018-06-28
07613327353976Aero-CStryker CorporationODP2018-06-28
07613327347036Tritanium CStryker CorporationODP2017-09-18
07613327347050Tritanium CStryker CorporationODP2017-09-18
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07613327349535Tritanium CStryker CorporationODP2017-09-18
07613327360035Tritanium CStryker CorporationODP2017-09-18
07613327360103Tritanium CStryker CorporationODP2017-09-18
07613327360257Tritanium CStryker CorporationODP2017-09-18
07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18
07613252602774AVS Anchor-LStryker CorporationODP2016-09-24