FDA.reportPublic FDA data

Cornice

Primary DI
B638CN0010
Brand
Cornice
Company
LEGEND SPINE LLC
Model
CN-001
Catalog number
CN-001
Published
2020-02-10
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
B638CN0010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017916474Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00763000880477|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.ODP2026-06-22
00763000880484|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.ODP2026-06-22
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.ODP2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.ODP2026-06-05
08809986491008BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491015BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491022BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491039BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04