FDA.reportPublic FDA data

Emerald Cervical PEEK

Primary DI
B104CP0360
Brand
Emerald Cervical PEEK
Company
GLASIR MEDICAL LP
Model
C-P-036
Catalog number
C-P-036
Device description
11mm 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
B104CP0360PrimaryHIBCC0

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
B104CP0340Emerald Cervical PEEKC-P-034 C-P-034 2017-04-05
B104CP0350Emerald Cervical PEEKC-P-035 C-P-035 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809986491046BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491053BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491060BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491077BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491084BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491091BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491107BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491114BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491121BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491138BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986490742BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490759BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490766BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490773BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490780BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490797BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490803BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490810BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490827BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490834BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490841BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490858BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490865BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490872BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490889BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490896BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03