FDA.reportPublic FDA data

C-PS Peek Optima Cervical Interbody Spacer

Primary DI
M696CPS607S0
Brand
C-PS Peek Optima Cervical Interbody Spacer
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
CPS-607S
Device description
CERVICAL CAGE SIZER 7MM X 15MM
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K092540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092540000C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACERRsb Spine, LLC2010-01-27ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M696CPS607S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
775 636 8281Info@OrthoImplantCompany.com

Regulatory Flags#

DUNS number
070061160
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811998032150OIC Cannulated Screw System01-SHS102018-07-31
10811998036301OIC Intramedullary Nail System01-IM302018-07-31
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036394OIC Intramedullary Nail System01-IM412018-07-31
10811998036561OIC Intramedullary Nail System01-IM582018-08-07
10811998038022OIC Intramedullary Nail System01-IMSE032018-08-07
10811998038039OIC Intramedullary Nail System01-IMSE042018-08-07
M69601IM300OIC Intramedullary Nail System01-IM302017-02-01
M69601IM320OIC Intramedullary Nail System01-IM322017-02-01
M69601IM340OIC Intramedullary Nail System01-IM342017-02-01
M69601IM400OIC Intramedullary Nail System01-IM402017-02-01
M69601IM410OIC Intramedullary Nail System01-IM412017-02-01
M69601SHS100OIC Cannulated Screw System01-SHS102017-02-01
10811998039555OIC Variable Angle Small Fragment Locking Plate System01-SF272023-09-06
10811998033478OIC Variable Angle Small Fragment Locking Plate System01-SF112018-07-31
10811998033485OIC Variable Angle Small Fragment Locking Plate System01-SF122018-07-31
M69601SF110OIC Variable Angle Small Fragment Locking Plate System01-SF112017-02-01
M69601SF120OIC Variable Angle Small Fragment Locking Plate System01-SF122017-02-01

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
07613327347067Tritanium CStryker CorporationODP2017-09-18
07613327347098Tritanium CStryker CorporationODP2017-09-18
07613327347159Tritanium CStryker CorporationODP2017-09-18
07613327347197Tritanium CStryker CorporationODP2017-09-18
07613327347296Tritanium CStryker CorporationODP2017-09-18
07613327347333Tritanium CStryker CorporationODP2017-09-18
07613327347357Tritanium CStryker CorporationODP2017-09-18
07613327347364Tritanium CStryker CorporationODP2017-09-18
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