FDA.reportPublic FDA data

Conmed/Linvatec

Primary DI
B504OM50530800
Brand
Conmed/Linvatec
Company
Provision
Model
5053-080
Published
2018-08-31
Public version status
New
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
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504OM50530800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-480-7953customersupport@provisiondrs.c

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OM50711330ConMed Linvatec5071-1332026-02-24
B504OM50721010ConMed Linvatec5072-1012026-02-24
B504OMBR58201070250BrasselerBR5820-107-0252026-02-24
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504AE2273010DePuy Mitek 2273012018-04-05
B504AE2273020DePuy Mitek 2273022018-04-05
B504AE2273050DePuy Mitek 2273052018-04-05
B504CBEICA5874010Smith & NephewEICA5874-012018-04-03
B504CBEICA8875010Smith & NephewEICA8875-012018-04-03
B504CBEICA8898010Smith & NephewEICA8898-012018-04-03
B504EICA9820010Smith & NephewEICA9820-012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706927Z1 Shortened Starter BroachZimmer, Inc.HTR2026-03-19
10889981443351SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
10889981443368SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
00190776416690MillenniumAvalign Technologies, Inc.HTR2026-02-16
03662663109574Mergence-A Preparation InstrumentationHighridge Medical, LLCHTR2026-02-11
00190376538969Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
00190376538976Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
03662663083720ActivLHighridge Medical, LLCHTR2026-02-03
03662663083737ActivLHighridge Medical, LLCHTR2026-02-03
03662663083744ActivLHighridge Medical, LLCHTR2026-02-03
00889024705524Identity 40MM Inset Humeral ProtectorZimmer, Inc.HTR2026-01-16
00840180543955General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00840180545058General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00888480490289Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490296Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490302Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490319Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490326Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490333Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490340Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490357Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490364Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490371Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490388Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490395Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490401Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490418Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490425Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490432Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490449Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29