FDA.reportPublic FDA data

Geomax Reamer Set

Primary DI
07649990202396
Brand
Geomax Reamer Set
Company
Surgical Fusion Technologies GmbH
Model
1
Catalog number
T04-004
Device description
Tray for Geomax Reamer S-PI-Axx and Handle S, for SF Push-in Anchor Portfolio
Published
2025-10-01
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
07649990202396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649990202396076499902023967649990202396

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
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
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
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

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Primary DI, Brand, Company table
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