FDA.report

EMERGE Anterior Cervical Plate System

Primary DI
00195860013892
Brand
EMERGE Anterior Cervical Plate System
Company
Evolution Spine LLC
Model
100-A008
Catalog number
100-A008
Device description
CERVICAL DRILL 12 mm
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00195860013892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00195860013892001958600138921958600138920195860013892

GMDN Terms

TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes

TypeValueUnit
Length12Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(214)682-8536info@evolutionspine.com

Regulatory Flags

DUNS number
116940934
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00195860031841E3D-C Interbody System130-A133130-A1332026-02-20
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00195860031865E3D-C Interbody System130-A135130-A1352026-02-20
00195860031872E3D-C Interbody System130-A136130-A1362026-02-20
00195860031889E3D-C Interbody System130-A137130-A1372026-02-20
00195860031896E3D-C Interbody System130-A138130-A1382026-02-20
00195860031902E3D-C Interbody System130-A139130-A1392026-02-20
00195860031919E3D-C Interbody System130-A140130-A1402026-02-20
00195860031926E3D-C Interbody System130-A141130-A1412026-02-20
00195860031933E3D-C Interbody System130-A142130-A1422026-02-20
00195860031940E3D-C Interbody System130-A143130-A1432026-02-20
00195860031957E3D-C Interbody System130-A144130-A1442026-02-20
00195860031964E3D-C Interbody System130-A145130-A1452026-02-20
00195860031971E3D-C Interbody System130-A146130-A1462026-02-20
00195860031988E3D-C Interbody System130-A147130-A1472026-02-20
00195860031995E3D-C Interbody System130-A148130-A1482026-02-20

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