FDA Registration Active 🇮🇹 Italy

Gammatom S.r.l.

Reg #: 9681465 · FEI: 3002807113 · Expires 2026
Products
78
Proprietary Names
334
Establishment Types
1
Classifications
78

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Registration Details

Registration Name
Gammatom S.r.l.
Registration Number
9681465
FEI Number
3002807113
Status
Active
Expiry Year
2026
Initial Importer
No
Address
VIA XXIV MAGGIO, 14
City
GUANZATE (CO) Como
Country
IT

Owner / Operator

Firm Name
GAMMATOM Srl
Operator Number
9023536
Address
VIA XXIV MAGGIO, 14, --
City
GUANZATE
State
Como
Postal Code
22070
Country
IT
Correspondent
Andrea - Soldini

US Agent

Business Name
Donawa Consulting LLC
Contact Name
Stephen H. Lieberman
Address
4545 N. Ocean Blvd., Unit 11A
City
Boca Raton
ZIP
33431
Country
US
Phone
561 3020777 ext. 0

Products

Device Name Product Code
Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis PIX
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Thoracolumbosacral Pedicle Screw System NKB
Prosthesis, Elbow, Constrained, Cemented JDC
Dura Substitute GXQ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Screw, Fixation, Bone HWC
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Posterior Cervical Screw System NKG
Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
Prosthesis, Hip, Cement Restrictor JDK
Bone Cement, Posterior Screw Augmentation PML
Orthosis, Spinal Pedicle Fixation MNI
Culture Media, Anaerobic Transport JSL
Appliance, Fixation, Spinal Intervertebral Body KWQ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Plate, Bone JEY
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Pin, Fixation, Smooth HTY
Sacroiliac Joint Fixation OUR
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Container, Specimen Mailer And Storage, Sterile KDT
Orthopedic Augmented Reality SBF
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate OJB
Cement, Bone, Vertebroplasty NDN
Kit, Surgical Instrument, Disposable KDD
Prosthesis, Elbow, Semi-Constrained, Cemented JDB
Bandage, Liquid KMF
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Culture Media, Non-Propagating Transport JSM
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
Container, I.V. KPE
Fastener, Fixation, Nondegradable, Soft Tissue MBI
System, Transport, Aerobic JTW
Transport Systems, Anaerobic JTX
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Pedicle Screw Placement Guide PQC
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Plate, Fixation, Bone HRS
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Electrode, Electrocardiograph DRX
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Appliance, Fixation, Spinal Interlaminal KWP
Rod, Fixation, Intramedullary And Accessories HSB
Filler, Bone Void, Calcium Compound MQV
Staple, Fixation, Bone JDR
Bone Cement LOD
Orthopedic Manual Surgical Instrument LXH
Applicator, Absorbent Tipped, Sterile KXG
Sacroiliac Screw Placement Guide QSR
Bone Cement, Antibiotic MBB
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Brush, Scrub, Operating-Room GEC
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Barrier, Synthetic, Intraoral NPK
Tissue Adhesive For The Topical Approximation Of Skin MPN
System, Facet Screw Spinal Device MRW
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Bone Grafting Material, Synthetic LYC
Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Device, Specimen Collection LIO
Fastener, Fixation, Biodegradable, Soft Tissue MAI

Proprietary Names

CMD 24-1060 ProMade Elbow CMD 23-1434 ProMade Elbow CMD 24-1099 ProMade Elbow CMD 25-1263 ProMade ELbow CMD 25-1026 ProMade ELbow MPACT EXTENSION MOTO Partial Knee System & MOTO PFJ SMR REVERSE SHOULDER SYSTEM ENDO HEAD GMK TOTAL KNEE SYSTEM MPACT DM LINER CONVERTER Quadra-P Medacta Shoulder System MUST LT + MUST Extension GMK SPHERE CMD 25-1115 ProMade Elbow CMD 24-1623 ProMade Elbow CMD 25-1142 ProMade Elbow CMD 25-1082 ProMade Elbow CMD 25-1264 ProMade Elbow CMD 25-1245 ProMade Elbow CMD 24-1416 ProMade Elbow CMD 24-1613 ProMade Elbow CMD 25-1076 ProMade Elbow CMD 23-1428 ProMade Elbow CMD 24-1029 ProMade Elbow CMD 25-1406 ProMade Elbow CMD 24-1524 ProMade Elbow CMD 24-1186 ProMade Elbow CMD 24-1157 ProMade Elbow CMD 24-1503 ProMade Elbow CMD 25-1128 ProMade Elbow CMD 25-1324 ProMade Elbow CMD 24-1059 ProMade Elbow SYNTHECEL Dura Repair 7,5x7,5 cm SYNTHECEL Dura Repair 10x12 cm SYNTHECEL Dura Repair 2,5x7,5 cm SYNTHECEL Dura Repair 5x5 cm SYNTHECEL Dura Repair 2,5x2,5 cm SYNTHECEL Dura Repair 14x20 cm GMK REVISION EXTENSION AMISteam-C Extension size 00 VERSAFITCUP CC TRIO Shoulder Long Stem MOTO PFJ System SMR 140° Reverse Humeral Body M.U.S.T. MINI Posterior Cervical Screws System GMK Revision and Hinge - TiNbN SAM CRRT Unit SAM Cassette CRRT MOTO Partial Knee System GMK SHORT STEM MYSPINE PEDICLE SCREW PLACEMENT GUIDES BD BBL CultureSwab MaxV Plus Copan Venturi Transystem Amies Medium with Charcoal BD BBL CultureSwab BD BBL CultureSwab Plus HealthLink Transporter Copan M40 Transystem META-C CERVICAL PLATE Mpact® 3D Metal™ Implants and Augments 3D Metal™ MiniMax - Cementless anatomical stems size 9 Lateralized Glenosphere MectaLIF Anterior Stand Alone Extension AMIS-K Long MECTACER BIOLOX FORTE-FEMORAL HEADS VERSAFIT CUP DOUBLE MOBILITY SYSTEM Shoulder SensiTiN SMR Hybrid Glenoid System MectaLIF Anterior Stand-Alone MUST Mini Extension PRIMA TT Glenoid M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System BD Inoculation Loops Disposable Transfer Pipettes GMK HINGE BC+ Dry Swab Tube NextAR TKA Platform Humeral Eccentric Reverse metaphysis MasterLoc Stem: Lateralized Plus SMS Stem sizes 1-2-14-15 TEMA Elbow system - Line extension TearRepair Liquid Skin Protectant Bone Screw Revision Bone Screw Locking Bone Screw SMR 40MM GLENOSPHERE SMR TT METAL BACK GLENOID Copan Venturi Transystem Amies Medium With Charcoal SMR Shoulder System SMS collared AMISteam-P Short Neck MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H QUADRA H QUADRA S SMR Stemless Anatomic PVC - Free Empty IV Mixing Container Copan Venturi Transystem Liquid Amies Medium BD BBL CultureSwab MaxV M-ARS ACL: Anatomic Ribbon Surgery System Copan Liquid Amies ESwab BD ESwab PHYSICA KR KNEE SYSTEM AMF TT Cones MySpine Extension Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Copan Easy-Swab Collection and Transport System BD BBL CultureSwab EZ M-Vizion Femoral Revision System Extension M.U.S.T. Combined Set Screws Delta Dual Mobility System Delta Multihole TT Pro Acetabular System Copan Venturi Transystem Cary-Blair Medium SMR TT Augmented Glenoid System M.U.S.T. MC Cross Connector FasTip Copan Venturi Transystem Amies Medium Without Charcoal GMK Revision Femoral Distal Augmentation MECTALIF TRANSFORAMINAL MectaLIF Extension GMK - LINE EXTENSION MECTALIF ANTERIOR Elos Intramedullary Nailing System MySpine Pedicle Screw Placement Guides - LP DIMI RRT System GMK Hinge GMK Revision MECTA-C Delta TT Pro VERSAFITCUP CC TRIO EXTENSION MectaLIF Anterior 3DMetal Tibial Cones Ligament staple MasterLoc Stem PAO Cortical Screw Glenoid Polyaxial Non-locking Screw M.U.S.T. Pedicle Screw System Medacta Shoulder System Short Humeral Diaphysis MECTACER BIOLOX OPTION HEADS M.U.S.T PEDICLE SCREW SYSTEM Protection Sleeve & Trocar MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments EVOLIS TOTAL KNEE SYSTEM M-Vizion Femoral Revision System Monobloc Polyester Fiber Swab, Sterile Cotton Fiber Swab, Sterile Nylon Fiber Swab, Sterile Rayon Fiber Swab, Sterile CLASSIQSwab GMK NARROW M.U.S.T. EXTENSION MectaLIF Posterior Extension Copan Venturi Transystem Stuarts Medium MySpine Guides Physica system GMK Sphere Revision Medacta Anatomic Shoulder Prosthesis Mecta-C TiPEEK GMK EXTENSION InterSpace GV Hip Tapered Wedge stem CMD 24-1491 ProMade Hip CMD 24-1586 ProMade Hip CMD 24-1441 ProMade Hip CMD 24-1439 ProMade Hip CMD 24-1417 ProMade Hip CMD 24-1336 ProMade Hip CMD 24-1137 ProMade Hip CMD 24-1396 ProMade Hip CMD 24-1278 ProMade Hip CMD 24-1454 ProMade Hip CMD 24-1434 ProMade Hip CMD 24-1494 ProMade Hip CMD 24-1568 ProMade Hip CMD 24-1298 ProMade Hip MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT MectaLIF Anterior Stand Alone Mpact Double Mobility System Cepheid Liquid Stuart Venturi Transystem Copan Venturi Transystem Liquid Stuarts Medium CultureSwab ALLIGENCE GMK 3D Metal Tibial Tray MECTALIF TIPEEK MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK MySpine S2-AlarAlar-Iliac Pedicle Screws Placement Guides CMD 25-1223 ProMade Shoulder CMD 24-1326 ProMade Shoulder CMD 25-1164 ProMade Shoulder CMD 25-1136 ProMade Shoulder CMD 25-1274 ProMade Shoulder CMD 25-1038 ProMade Shoulder CMD 25-1163 ProMade Shoulder CMD 24-1592 ProMade Shoulder CMD 24-1423 ProMade Shoulder CMD 24-1556 ProMade Shoulder CMD 24-1616 ProMade Shoulder CMD 24-1410 ProMade Shoulder CMD 24-1362 ProMade Shoulder CMD 25-1260 ProMade Shoulder CMD 24-1463 ProMade Shoulder CMD 25-1435 ProMade Shoulder CMD 24-1620 ProMade Shoulder CMD 25-1459 ProMade Shoulder CMD 24-1457 ProMade Shoulder CMD 25-1176 ProMade Shoulder CMD 24-1655 ProMade Shoulder CMD 25-1079 ProMade Shoulder CMD 24-1365 ProMade Shoulder CMD 24-1486 ProMade Shoulder CMD 25-1411 ProMade Shoulder CMD 24-1456 ProMade Shoulder CMD 24-1429 ProMade Shoulder CMD 24-1380 ProMade Shoulder CMD 24-1481 ProMade Shoulder CMD 25-1436 ProMade Shoulder CMD 25-1217 ProMade Shoulder CMD 25-1233 ProMade Shoulder CMD 25-1444 ProMade Shoulder CMD 24-1629 ProMade Shoulder CMD 24-1375 ProMade Shoulder CMD 25-1151 ProMade Shoulder CMD 25-1138 ProMade Shoulder CMD 24-1446 ProMade Shoulder CMD 24-1542 ProMade Shoulder CMD 24-1224 ProMade Shoulder CMD 25-1460 ProMade Shoulder CMD 24-1562 ProMade Shoulder CMD 24-1263 ProMade Shoulder CMD 24-1470 ProMade Shoulder CMD 25-1248 ProMade Shoulder CMD 25-1110 ProMade Shoulder CMD 25-1253 ProMade Shoulder CMD 24-1405 ProMade Shoulder CMD 25-1336 ProMade Shoulder CMD 25-1071 ProMade Shoulder CMD 24-1422 ProMade Shoulder CMD 24-1509 ProMade Shoulder CMD 25-1024 ProMade Shoulder CMD 24-1347 ProMade Shoulder CMD 25-1042 ProMade Shoulder CMD 24-1327 ProMade Shoulder CMD 25-1369 ProMade Shoulder CMD 25-1111 ProMade Shoulder CMD 24-1240 ProMade Shoulder CMD 24-1132 Promade Shoulder CMD 25-1165 ProMade Shoulder CMD 24-1639 ProMade Shoulder Mecta-C Stand Alone Extension Kite Distal Fibula Kit MECTALIF SMS EcoFLX Empty Mixing Container MUST SI Headless extension M.U.S.T. MINI Posterior Cervical Screw System - OC SpheriKa TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT VCFix Spinal System Mpact 3D Metal DMLS Copan Venturi Transystem Amies Medium without Charcoal NextAR Spine Platform GMK SPHERE e-cross MPACT ACETABULAR SYSTEM MINIMA S SYSTEM Bone Screws dia. 50 mm BondEase 2 Topical Skin Adhesive GMK SPHERE EXTENSION FairFix Adjustable Button System - Round buttons MasterLoc Stem - Sizes 13 and 14 SYSTEM, FACET CREW SPINAL DEVICE MectaScrew C NextAR RSA Platform M.U.S.T. SI screw and pelvic trauma system MyKnee PPS-Pin Positioners Femoral Component 3D Metal Diaphyseal Femoral Cones AMIStem-H Proximal Coating Medacta Shoulder System: Threaded Glenoid Baseplate MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION MiniMAX M.U.S.T. MINI Posterior Cervical Screw System - Straight rods Copan Viral Transystem CMD 24-1393 ProMade Hip FairFix Adjustable Button System PRIMA Humeral System and SMR Glenosphere D 42 MyKnee R NextAR Knee Platform MectaScrew PEEK Interference Screw GMK UNI dressing, wound, drug MectaLIF Transforaminal TiPEEK M-Vizion Femoral Revision System MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS CMD 25-1271 ProMade Hip CMD 25-1362 ProMade Hip CMD 24-1603 ProMade Hip CMD 25-1228 ProMade Hip CMD 25-1053 ProMade Hip CMD 25-1446 ProMade Hip CMD 24-1584 ProMade Hip CMD 24-1610 ProMade Hip CMD 25-1081 ProMade Hip CMD 25-1008 ProMade Hip CMD 25-1416 ProMade Hip CMD 25-1083 ProMade Hip CMD 24-1641 ProMade Hip CMD 25-1137 ProMade Hip CMD 25-1131 ProMade Hip CMD 25-1402 ProMade Hip CMD 25-1238 ProMade Hip CMD 25-1313 ProMade Hip CMD 25-1207 ProMade Hip CMD 25-1075 ProMade Hip SMR Finned Short Stems MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C Mpres DM Converter TiN M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws PRIMA Humeral System; PRIMA TT Glenoid Quadra-P SN 00 STD AMIStem-H Proximal Coating AMIStem-P and AMIStem-P Collared Kyphon VuE™ Bone Cement Trinity EVO Acetabular Shell Revision Femoral Head M.U.S.T. Mini extension AMISTEM AND QUADRA - LINE EXTENSION MYKNEE CUTTING BLOCKS SMR Lateralized Connectors with screws GMK Total Knee System - TiNbN Coating EXACTAMIX EMPTY EVA BAG MOTO Lateral Partial Knee System MPACT extension Copan FecalSwab MECTACER BIOLOX(R) DELTA FEMORAL HEADS M-Vizion Extension Mecta-C Stand Alone M.U.S.T. Midline Cortical GMK REVISION KNEE SYSTEM

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)