FDA.reportPublic FDA data

ENDURA

Primary DI
20845854020323
Brand
ENDURA
Company
Conmed Corporation
Model
C9013
Catalog number
C9013
Device description
ENDURA SPHERICAL BUR, 3.5 MM
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943985000LIMITED REUSE BLADESLinvatec Corp.1994-11-07HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854020320Direct MarkingGS10
20845854020323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585402032030845854020320
2084585402032320845854020323

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
00841731153135ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153142ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153159ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153166ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
03700879515540airlock®NOVASTEPHWE2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00842078125724CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09