FDA.reportPublic FDA data

POWEREASE™ Instruments

Primary DI
00763000679682
Brand
POWEREASE™ Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2343435
Device description
SLEEVE 2343435 15MM SLEEVE
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFStimulator, electrical, evoked response
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111520000IPC POWEREASE SYSTEMMedtronic Xomed, Inc.2011-10-26HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000679682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000679682007630006796827630006796820763000679682

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19
00643169511729MSB SOVEREIGN™ Spinal System90100020322026-07-19
00643169511736MSB SOVEREIGN™ Spinal System90100020332026-07-19
00643169511774MSB SOVEREIGN™ Spinal System90100020342026-07-19
00643169511781MSB SOVEREIGN™ Spinal System90100020352026-07-19
00643169511798MSB SOVEREIGN™ Spinal System90100020362026-07-19
00643169511804MSB SOVEREIGN™ Spinal System90100020372026-07-19
00643169511811MSB SOVEREIGN™ Spinal System90100020382026-07-19
00643169511828MSB SOVEREIGN™ Spinal System90100020392026-07-19
00643169511873MSB SOVEREIGN™ Spinal System90100020052026-07-19
00643169511880MSB SOVEREIGN™ Spinal System90100020062026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
03700879515540airlock®NOVASTEPHWE2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
10886982237217NASYNTHES (U.S.A.) LPHWE2019-02-21
10886982237613NASynthes GmbHHWE2017-02-20
10886982129512NASynthes GmbHHWE2016-12-31
10886982129598NASynthes GmbHHWE2016-12-31
10886982237729NASynthes GmbHHWE2016-12-31
10886982237989NASynthes GmbHHWE2016-12-31
10886982238795NASynthes GmbHHWE2016-12-31
10886982240323NASynthes GmbHHWE2016-12-31
10886982240347NASynthes GmbHHWE2016-12-31
10886982240361NASynthes GmbHHWE2016-12-31
10886982240385NASynthes GmbHHWE2016-12-31
10886982064721NASynthes GmbHHWE2016-06-30
10886982064721NASynthes GmbHHBE2016-06-30
10886982064738NASynthes GmbHHWE2016-06-30
10886982064738NASynthes GmbHHBE2016-06-30
10886982064745NASYNTHES (U.S.A.) LPHWE2016-06-30
10886982064745NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064820NASYNTHES (U.S.A.) LPHBE2016-06-30