FDA Registration
Active
🇨🇭 Switzerland
INNOTOOL&GREMINGER AG
Reg #: 3010314800
·
FEI: 3010314800
·
Expires 2026
Products
28
Proprietary Names
262
Establishment Types
1
Classifications
28
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Registration Details
- Registration Name
- INNOTOOL&GREMINGER AG
- Registration Number
- 3010314800
- FEI Number
- 3010314800
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Fabrikstrasse 1E
- City
- Erlen Thurgau
- Country
- CH
Owner / Operator
- Firm Name
- innotool & greminger ag
- Operator Number
- 10043239
- Address
- Fabrikstrasse 1E
- City
- Erlen
- State
- Thurgau
- Postal Code
- 8586
- Country
- CH
- Correspondent
- David Kreizer
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-12-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-12-12 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-12-12 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-12-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2025-12-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-31 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-10-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-10-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-11-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-11-03 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2015-03-03 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2015-03-03 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2015-03-03 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2015-03-03 |
| Guard, Instrument | LXZ | Class 1 | General, Plastic Surgery | No | 2026-04-20 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-31 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-01-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-12-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-12-19 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-31 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-31 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2024-12-19 |
Proprietary Names
Avenir Manipulierh. Trunnion Verb. Std
Avenir Manipulierhals MIS Rasp. Standard
Avenir MIS Raspel Gr. 3
Avenir Raspel Trunnion Verbindung Gr. 3
Avenir MIS Raspel Gr. 5
Avenir MIS Raspel Gr. 1
Avenir Raspel Trunnion Verbindung Gr. 8
Avenir Raspel Trunnion Verbindung Gr. 7
Avenir MIS Raspel Gr. 7
Avenir Raspel Trunnion Verbindung Gr. 5
Avenir Raspel Trunnion Verbindung Gr. 6
Avenir Manipulierhals MIS Raspel Lateral
Avenir MIS Raspel Gr. 6
Avenir MIS Raspel Gr. 2
Avenir Raspel Trunnion Verbindung Gr. 1
Avenir Raspel Trunnion Verbindung Gr. 9
Avenir Raspel Trunnion Verbindung Gr. 2
Avenir MIS Raspel Gr. 8
Avenir Manipulierh. Trunnion Verb. Lat.
Avenir Raspel Trunnion Verbindung Gr. 4
Avenir MIS Raspel Gr. 9
Avenir MIS Raspel Gr. 4
RESURFACING Cup Inserter Size 64 / X
RESURFACING Cup Inserter curved 66/Z
RESURFACING Cup Inserter curved 64/X
RESURFACING Cup Inserter curved 52/L
ANATOMICAL Handle for rasp
RESURFACING Base plate holder standard
RESURFACING Cup Inserter Size 46 / F
RESURFACING Cup Inserter Size 48 / H
RESURFACING Cup Inserter Size 44 / D
RESURFACING Cup Inserter curved 48/H
ANATOMICAL adapter
RESURFACING Cup Inserter curved 54/N
RESURFACING Cup Inserter Size 62 / V
MUTARS® Gleithammer
MUTARS® Gabelschluessel SW 24
Pin-Einschlaeger 3,2mm
AGILON® Einschlaghuelse M6
Glenoid Positionierer
AGILON® humerus resection protection plate round sz. XS
Uni FB fin chisel right
ACS® Uni femoral fin punch size 1
ACS® Uni SG femoral reaming guide 3mm
ACS® Uni femoral fin punch size 2
ACS® Uni femoral fin punch size 3
ACS® Uni SG femoral reaming guide 4mm
ACS® Uni SG femoral reaming guide 1mm
angled drill guide 3,2mm
ACS® Uni SG femoral reaming guide 2mm
Uni FB Adapter for tibial resection
ACS® Uni SG femoral reaming guide 5mm
Uni FB fin chisel left
RESURFACING Cup Inserter Size 52 / L
ic-impactor
RESURFACING Cup Coupling Handle curved
RESURFACING Cup Inserter Size 66 / Z
RESURFACING Base plate holder small
RESURFACING Cup Inserter curved 56/P
RESURFACING Cup Inserter curved 62/V
RESURFACING Cup Inserter Size 58 / R
RESURFACING Cup Inserter curved 58/R
RESURFACING Cup Inserter Size 56 / P
ACS® Uni femoral fin punch size 4
RESURFACING Screw M6 for 010219.833
ANATOMICAL Screw for rasp
Chisel angled
RESURFACING Cup Inserter curved 44/D
ACS® Uni SG femoral reaming guide 0mm
RESURFACING Cup Inserter Size 50 / J
Grab
RESURFACING Cup Inserter curved 46/F
RESURFACING Cup Inserter Size 60 / T
RESURFACING Cup Inserter curved 50/J
RESURFACING Cup Inserter Size 54 / N
RESURFACING Impactor curved
RESURFACING Cup Inserter curved 60/T
Glenoid Bohrschablone Gr.4
Glenoid Bohrschablone Gr.3
Glenoid Bohrschablone Gr.2
NCB-DF Verbindungsbolzen L 144mm
Einschlaginstrument
Alloclassic®, SLL trial rasp, 9
Alloclassic®, SLL trial rasp, 5
Alloclassic®, SLL trial rasp, 10
Alloclassic®, SLL trial rasp, 4
Alloclassic®, SLL trial rasp, 3
Alloclassic®, SLL trial rasp, 8
Alloclassic®, SLL trial rasp, 7
Alloclassic®, SLL trial rasp, 11
Alloclassic®, SLL trial rasp, 6
Trial cup D 67mm
Trial cup D 49mm
Trial cup D 50mm
Trial cup D 57mm
Trial cup D 62mm
Trial cup D 59mm
Trial cup D 60mm
Trial adapter M/0; 12/14
Trial cup D 54mm
Trial cup D 53mm
RESURFACING Femoral trial size 40 / F
RESURFACING Femoral trial size 60 / Z
Trial cup D 45mm
Trial cup D 48mm
Trial cup D 44mm
Trial adapter L/+4; 12/14
Trial cup D 56mm
Trial cup D 63mm
RESURFACING Femoral trial size 58 / X
ACS® FB trial PE insert 2/12,5mm
ACS® FB trial PE insert 2/10mm
Trial cup D 47mm
Trial cup D 66mm
Trial adapter XL/+8; 12/14
ANATOMICAL Test ball-taper
Trial adapter S/-4; 12/14
Trial cup D 52mm
Trial cup D 55mm
Trial cup D 46mm
Trial cup D 65mm
CLS Testhead 135° 32 M blue
Trial cup D 61mm
Trial cup D 64mm
Trial cup D 58mm
Trial cup D 51mm
RESURFACING Femoral trial size 38 / D
AS FX EXTENSION ROD
AS FX Handle for rasp
Fitmore, kurvierter Meissel
FITMORE KNSTSTFFBCKN F10559.620 PK/2
Anatomical Shoulder Rasp for humeral stem 7
Anatomical Shoulder Rasp for humeral stem 9
AS FX Kontroll-Stab
AS FX Screw for Humerus Testkopf
Anatomical Shoulder Rasp for humeral stem 6
Anatomical Shoulder Rasp for humeral stem 16
Anatomical Shoulder Rasp for humeral stem 18
Anatomical Shoulder Rasp for humeral stem 5
AS screw for Rasp
Anatomical Shoulder Rasp for humeral stem 14
X-Stift
Anatomical Shoulder Rasp for humeral stem 12
Anatomical Shoulder Rasp for humeral stem 10,5
MUTARS® rasp for femoral stem 13mm
MUTARS® rasp for femoral stem 20mm
MUTARS® rasp for femoral stem 15mm
MUTARS® rasp for femoral stem 16mm
MUTARS® rasp for femoral stem 14mm
MUTARS® rasp for femoral stem 18mm
MUTARS® rasp for femoral stem 17mm
MUTARS® rasp for femoral stem 12mm
MUTARS® rasp for femoral stem 19mm
Richtaufsatz f Flachprofil-Pfannen 22mm
Adapter mit Kipphebel
implaFit® trial neck K12/14 std. stem 6+7
implaFit® trial neck K12/14 lat. stem 8+9
implaFit® trial neck K12/14 std. stem 4+5
implaFit® trial neck K12/14 std. stem 2+3
implaFit® trial neck K12/14 lat. stem 2+3
implaFit® trial neck K12/14 lat. stem 10
implaFit® trial neck K12/14 std. stem 8+9
implaFit® trial neck K12/14 lat. stem 6+7
implaFit® trial neck K12/14 std. stem 1
implaFit® trial neck K12/14 lat. stem 1
implaFit® trial neck K12/14 lat. stem 4+5
implaFit® trial neck K12/14 std. stem 10
MIS ALLOFIT curved Impactor
Assembly inlay
Allofit Offset Shell Impactor
MUTARS® Einschlaginstrument
cap impactor dia. 32-44
Glenosphaerensetzer dia. 32-44
pin inserter 3,2 mm
AGILON® impactor screw trauma
MUTARS® universal impactor
Assembly attachment 12/14
AS B/F Silhouette 45°
Extraction instrument straight
stem extractor M6 x 0,75
ic-extractor adapter M5
AS I/R Handle Glenoid Adapter
AS I/R Glenoid Adapter, Revision
Durom/Trilogy cur. inserter adap. 50/44J
Durom/Trilogy cur. inserter adap. 62/56V
Durom/Trilogy cur. inserter adap. 64/58X
AS FX Control rod
Durom/Trilogy cur. inserter adap. 46/40F
Durom/Trilogy cur. inserter adap. 56/50P
Durom/Trilogy cur. inserter adap. 58/52R
Durom/Trilogy cur. inserter adap. 54/48N
Durom/Trilogy cur. inserter adap. 60/54T
ANATOMICAL Drilling guide, revision
Durom/Trilogy cur. inserter adap. 44/38D
Durom/Trilogy cur. inserter adap. 52/46L
Durom/Trilogy cur. inserter adap. 66/60Z
Durom/Trilogy cur. inserter adap. 48/42H
AGILON® XO drill for glenoid central screw 25 mm
AGILON® box chisel universal
AGILON® metaphyseal counter instrument
AGILON® XO drill for glenoid central screw 35 mm
AGILON® impactor universal
AGILON® XO drill for glenoid central screw 30 mm
Repositioning top ø 36
Cannulated drill for cemented glenoid
Uni FB peg drill
MK 4in1 attachment notch preparation 5-6
ACS® SC FB tibial reaming guide 5 right
ACS® SC FB tibial reaming guide 6 left
ACS® SC FB tibial reaming guide 3 right
ACS® SC FB tibial reaming guide 2 right
ACS® SC FB tibial reaming guide 2 left
ACS® SC FB tibial reaming guide 4 right
ACS® SC FB tibial reaming guide sz. 3,5 right
ACS® SC FB tibial reaming guide sz. 3,5 left
MK 4in1 attachment notch preparation 2-4
ACS® SC FB tibial reaming guide 5 left
ACS® SC FB tibial reaming guide 6 right
ACS® spacer shim 12,5mm
ACS® SC FB tibial reaming guide 4 left
ACS® SC FB tibial reaming guide 3 left
AGILON® impactor universal part 1
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 23
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 16
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 23
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 19
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 20
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 14
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 18
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 15
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 13
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 21
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 18
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 22
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 17
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 20
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 16
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 19
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 21
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 15
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 22
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 14
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 17
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 13
Wagner Cone Prosthesis®, trial stem, proximal, 125, ø 24
Wagner Cone Prosthesis®, trial stem, proximal, 135, ø 24
Wagner Cone Prosthesis®, screw for trial stem
Schraubendreher lang 3,5mm
Hexagonal screw driver short 3.5mm AO small
Screwdriver for extraction instrument
RESURFACING Femoral pusher
Repositioning top ø 22
implaFit® broach sz. 5
implaFit® broach sz. 7
implaFit® broach sz. 3
implaFit® broach sz. 8
implaFit® broach sz. 1
implaFit® broach sz. 4
implaFit® broach sz. 6
implaFit® broach sz. 9
implaFit® broach sz. 10
implaFit® broach sz. 2
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)