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

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical system handpiece tipA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

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
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
10886982064721NASynthes GmbHDZI2016-06-30
10886982064721NASynthes GmbHHBE2016-06-30
10886982064738NASynthes GmbHHBE2016-06-30
10886982064738NASynthes GmbHDZI2016-06-30
10886982064745NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064745NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064820NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064820NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064844NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064844NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064882NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064882NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064905NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064905NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064912NASynthes GmbHDZI2016-06-30
10886982064912NASynthes GmbHHBE2016-06-30
10886982064929NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064929NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064936NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064936NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064943NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064943NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982065001NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982065001NASYNTHES (U.S.A.) LPDZI2016-06-30