FDA.reportPublic FDA data

MECTRON

Primary DI
E322036000210
Brand
MECTRON
Company
MECTRON SPA
Model
MT1520+
Catalog number
03600021
Device description
Insert MT1520+ is an osteotomy surgical insert to be used in conjuction with Mectron Piezosurgery hanpieces
Published
2023-06-20
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
DZIDrill, Bone, Powered
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153743000PIEZOSURGERY PLUSMectron S.P.A.2016-05-25JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E322036000210PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16144594922info@piezosurgery.us

Regulatory Flags#

DUNS number
436664734
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E322036000220MECTRONMT1817L036000222026-04-20
E322036300090MECTRONMF1004L036300092026-04-20
E322033800150MECTRONOP1125033800152026-02-18
E322033800160MECTRONOP1225033800162026-02-18
E322034000110MECTRONEX0410034000112026-02-18
E322034000120MECTRONEX0510034000122026-02-18
E322034000130MECTRONEX0610034000132026-02-18
E322048000111010MECTRONPD0620A -US-04800011-1012026-02-18
E322048000121010MECTRONPD0620B -US-04800012-1012026-02-18
E322051000851010MECTRONstarlight pro - SHINY YELLOW -USA05100085-1012025-06-17
E322051000861010MECTRONstarlight pro - MATT BLACK -USA05100086-1012025-06-17
E322051000871010MECTRONstarlight pro - SHINY SILVER -USA05100087-1012025-06-17
E322031202490010MECTRONMANIPOLO PIEZOSURGERY® medical +03120249-0012025-06-16
E322036300080MECTRONMF0804+036300082025-06-16
E322051000831010MECTRONstarlight pro - SHINY WHITE -USA05100083-1012025-06-16
E322048000011010MECTRONPD0118A -US-04800001-1012024-10-15
E322048000021010MECTRONPD0223A -US-04800002-1012024-10-15
E322048000031010MECTRONPD0328A -US-04800003-1012024-10-15
E322048000041010MECTRONPD0432A -US-04800004-1012024-10-15
E322048000051010MECTRONPD0535A -US-04800005-1012024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03609820875712ACTEONSATELECDZI2026-10-13
03609820875743ACTEONSATELECDZI2026-10-13
04560264508422VA-SG-SCNAKANISHI INC.DZI2026-10-05
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-07-08
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-07-08
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2021-05-21
00763000216719CD HORIZON® SOLERA® VOYAGER™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HBE2020-12-31
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2019-06-08
10887587057026NASynthes GmbHDZI2019-02-22
10887587057026NASynthes GmbHHBE2019-02-22
04546540246332NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246356NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246387NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246974NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246981NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540251862NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337818DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337825DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337900DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356499NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356505NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356512NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356529NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356536NAStryker Leibinger GmbH & Co. KGHBE2016-08-24