FDA.reportPublic FDA data

EVOL®SI Joint Fusion System

Primary DI
00841193122427
Brand
EVOL®SI Joint Fusion System
Company
Cutting Edge Spine, LLC
Model
CES-291
Catalog number
CES-291
Device description
EVOL®SI, Depth Gauge
Published
2019-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841193122427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841193122427008411931224278411931224270841193122427

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, plasticA non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device.

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
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
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