FDA.reportPublic FDA data

SupraFuser Generator

Primary DI
07649990202075
Brand
SupraFuser Generator
Company
Surgical Fusion Technologies GmbH
Model
SupraFuser Generator
Catalog number
SF04-005
Published
2024-04-12
Public version status
New
Distribution status
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
HWCScrew, Fixation, Bone
MAIFastener, Fixation, Biodegradable, Soft Tissue
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240288000SF Push- in AnchorSurgical Fusion Technologies GmbH2024-04-01MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649990202075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649990202075076499902020757649990202075

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482948937
Device count
1
Serial number
true
Manufacturing date on label
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
07649990202051Wrench 5.0Wrench 5.0GS04-0022023-12-14
07649990202143HandpieceHandpiece H04-0012023-12-14
07649990202150BoneWelder 150-W1BoneWelder 150-W1BW04-0012023-12-14
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
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00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
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00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
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00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12