FDA.reportPublic FDA data

Emerald Cervical PEEK

Primary DI
B104CP0340
Brand
Emerald Cervical PEEK
Company
GLASIR MEDICAL LP
Model
C-P-034
Catalog number
C-P-034
Device description
9mm Emerald Parallel Cervical PEEK
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K110659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110659000MEDICAL CONCEPTS INTERBODY FUSION SYSTEMMedical Concepts, Inc.2011-09-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B104CP0340PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
066151033
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B104CL0300Emerald Cervical PEEKC-L-030C-L-0302017-04-05
B104CL0310Emerald Cervical PEEKC-L-031 C-L-031 2017-03-29
B104CL0320Emerald Cervical PEEKC-L-032 C-L-032 2017-04-05
B104CL0330Emerald Cervical PEEKC-L-033 C-L-033 2017-04-05
B104CL0340Emerald Cervical PEEKC-L-034 C-L-034 2017-04-05
B104CL0350Emerald Cervical PEEKC-L-035 C-L-035 2017-04-05
B104CL0360Emerald Cervical PEEKC-L-036 C-L-036 2017-04-05
B104CL0370Emerald Cervical PEEKC-L-037 C-L-037 2017-04-05
B104CP0300Emerald Cervical PEEKC-P-030 C-P-030 2017-04-05
B104CP0310Emerald Cervical PEEKC-P-031 C-P-031 2017-04-05
B104CP0320Emerald Cervical PEEKC-P-032 C-P-032 2017-04-05
B104CP0330Emerald Cervical PEEKC-P-033 C-P-033 2017-04-05
B104CP0350Emerald Cervical PEEKC-P-035 C-P-035 2017-04-05
B104CP0360Emerald Cervical PEEKC-P-036 C-P-036 2017-04-05
B104CP0370Emerald Cervical PEEKC-P-037 C-P-037 2017-04-05
B104P092506000Onyx PLIF PEEKP09250600P092506002017-04-05
B104P092507000Onyx PLIF PEEKP09250700P092507002017-04-05
B104P092507100Onyx PLIF PEEKP09250710P092507102017-04-05
B104P092508000Onyx PLIF PEEKP09250800P092508002017-04-05
B104P092509000Onyx PLIF PEEKP09250900P092509002017-04-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION 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
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07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18