FDA.reportPublic FDA data

ConMed

Primary DI
B504ASSDPSC0020
Brand
ConMed
Company
Provision
Model
SDPS-C002
Published
2022-10-17
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172092000Reprocessed Shavers/BursRenovo, Inc.2017-10-04HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504ASSDPSC0020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, reprocessedA powered, cutting device designed for use in an arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a previously used single-use device that has been processed for an additional single-use patient application.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature7 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-422-8880mark@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM 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
B504GS80200Vericel80202026-07-20
B504GS80210Vericel80212026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20
B504OM4058890Biomet4058892026-07-20
B504OM41251470900Stryker4125-147-0902026-07-20
B504OM50711850Conmed Linvatec5071-1852026-07-20
B504OM51003372330Stryker5100-337-2332026-07-20
B504OM542022S0Stryker542022S2026-07-20
B504OM7024470Stryker7024472026-07-20
B504OMA37330MedartisA-37332026-07-20
B504OMAR1214L0ArthrexAR-1214L2026-07-20
B504OMAR1217L0ArthrexAR-1217L2026-07-20
B504OMAR14510ArthrexAR-14512026-07-20
B504OMCSS07247SQ0WrightCSS-072-47-SQ2026-07-20
B504OMKM166310260BrasselerKM166-310-262026-07-20
B504OMKM166310680BrasselerKM166-310-682026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
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
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25