FDA.reportPublic FDA data

COALESCE

Primary DI
B1422000000908080
Brand
COALESCE
Company
VERTERA, INC.
Model
2000-00-090808
Device description
9x23x8MM COALESCE-Straight, Lordotic
Published
2017-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143685000Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.2015-09-23ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1422000000908080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA 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) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078812764
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14211000000010Cohere1100-00-00012018-11-09
B14211000000140Cohere1100-00-00142018-11-09
B14211000000160Cohere1100-00-00162018-11-09
B14211000100010Cohere1100-01-00012018-11-09
B1422000001012080COALESCE2000-00-1012082018-11-09
B1422000001014080COALESCE2000-00-1014082018-11-09
B14220000128080COALESCE2000-01-28082018-11-09
B14220000128090COALESCE2000-01-28092018-11-09
B14220000128100COALESCE2000-01-28102018-11-09
B14220000128110COALESCE2000-01-28112018-11-09
B14220000128120COALESCE2000-01-28122018-11-09
B14220000128140COALESCE2000-01-28142018-11-09
B14220000132090COALESCE2000-01-32092018-11-09
B14220000132100COALESCE2000-01-32102018-11-09
B14220000132110COALESCE2000-01-32112018-11-09
B14220000132120COALESCE2000-01-32122018-11-09
B14220000132140COALESCE2000-01-32142018-11-09
B14220000132160COALESCE2000-01-32162018-11-09
B1422000000908000COALESCE2000-00-0908002017-11-09
B1422000000909000COALESCE2000-00-0909002017-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14