FDA.reportPublic FDA data

Wrench 5.0

Primary DI
07649990202051
Brand
Wrench 5.0
Company
Surgical Fusion Technologies GmbH
Model
Wrench 5.0
Catalog number
GS04-002
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
07649990202051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649990202051076499902020517649990202051

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
+41442046018complaints@surgical-fusion.com

Regulatory Flags#

DUNS number
482948937
Device count
1
Lot or batch
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
07649990202037Sonotrode PI-S 2.3Sonotrode PI-S 2.3S04-0012023-12-14
07649990202044Twist Drill PI-C 1.8Twist Drill PI-C 1.8F09-040022023-12-14
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
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24