FDA.reportPublic FDA data

EVOL®ha-C Cervical Interbody System

Primary DI
00841193121123
Brand
EVOL®ha-C Cervical Interbody System
Company
Cutting Edge Spine, LLC
Model
CES-384
Catalog number
CES-384
Device description
EVOL®ha-C Cervical TRIAL 16WX12D 7° 7H-8H
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180674000EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC2018-06-25ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841193121123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841193121123008411931211238411931211230841193121123

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement restrictor sizerA non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length400Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(704)243-0892B.Roof@cuttingedgespine.com

Regulatory Flags#

DUNS number
069472647
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841193127996T-FIX™3Dsi Joint Fusion SystemCES-6432026-03-24
00841193127521EVOL®ha-Hyper C Cervical Interbody System6012-0507A6012-0507A2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody System6012-0607A6012-0607A2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody System6012-0707A6012-0707A2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody System6012-0807A6012-0807A2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody System6012-0907A6012-0907A2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody System6012-1007A6012-1007A2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody System6012-1107A6012-1107A2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody System6012-1207A6012-1207A2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody System6013-0512A6013-0512A2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody System6013-0612A6013-0612A2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody System6013-0712A6013-0712A2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody System6013-0812A6013-0712A2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody System6013-0912A6013-0912A2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody System6013-1012A6013-1012A2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody System6013-1112A6013-1112A2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody System6013-1212A6013-1212A2026-03-11
00841193101934EVOS Lumbar Interbody System4014-0164014-0162015-10-30
00841193104836EVOS Lumbar Interbody System4067-0104067-0102015-10-30
00841193105635EVOS Lumbar Interbody System4004-0144004-0142016-01-12

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Primary DI, Brand, Company table
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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
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
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07613327353921Aero-CStryker CorporationODP2018-06-28
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