FDA.reportPublic FDA data

Sonotrode PI-S 2.3

Primary DI
07649990202037
Brand
Sonotrode PI-S 2.3
Company
Surgical Fusion Technologies GmbH
Model
Sonotrode PI-S 2.3
Catalog number
S04-001
Published
2023-12-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene
HTYPin, Fixation, Smooth
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HTYPin, Fixation, SmoothOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171228000Fiji AnchorSportwelding GmbH2018-01-19MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649990202037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649990202037076499902020377649990202037

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system generatorAn electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41 442046018complaints@surgical-fusion.com

Regulatory Flags#

DUNS number
482948937
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649990202419Drill S-PI-A1.6 extra shortDrill S-PI-A1.6 extra shortD04-1022026-01-18
07649990202174Geomax Reamer S-PI-A1.61.6R04-1012025-10-01
07649990202211Geomax Reamer S-PI-A2.32.3R04-0012025-10-01
07649990202372Geomax Reamer S-PI-A3.03.0R04-2012025-10-01
07649990202389Handle SSHD04-001 2025-10-01
07649990202396Geomax Reamer Set1 T04-004 2025-10-01
07649990202310Drill S-PI-A1.6Drill S-PI-A1.6D04-1012024-04-12
07649990202020Tray_SF Push-In Anchor 2.3Tray_SF Push-In Anchor 2.3T04-0022024-01-10
07649990202204SupraFuser B GeneratorSupraFuser B GeneratorSF04-005-B2024-02-06
07649990202013Tray_SF Push-in Anchor 2.3Tray_SF Push-in Anchor 2.3 BWT04-0012023-12-14
07649990202044Twist Drill PI-C 1.8Twist Drill PI-C 1.8F09-040022023-12-14
07649990202051Wrench 5.0Wrench 5.0GS04-0022023-12-14
07649990202143HandpieceHandpiece H04-0012023-12-14
07649990202150BoneWelder 150-W1BoneWelder 150-W1BW04-0012023-12-14
07649990202075SupraFuser GeneratorSupraFuser GeneratorSF04-0052024-04-12
07649990202228SF Push-in Anchor 1.6SF Push-in Anchor 1.6B04-4112024-04-12
07649990202235SF Push-in Anchor 3.0SF Push-in Anchor 3.0B04-4212024-04-12
07649990202259Stopper S-PI-A1.6Stopper S-PI-A1.6ST04-1012024-04-12
07649990202266Stopper S-PI-A2.3Stopper S-PI-A2.3ST04-0012024-04-12
07649990202273Stopper S-PI-A3.0Stopper S-PI-A3.0ST04-2012024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
07290019361206OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
10705031097889ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031102996ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031103085ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031238404ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461963ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461970ETHIBOND EXCELETHICON, LLCGAT2026-07-17
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
00888867304598Arthrex®ARTHREX, INC.MAI2026-07-08