Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010314800

FEI Number

3010314800

Entity Name

INNOTOOL&GREMINGER AG

City/State/Country

Erlen Thurgau, CH

Establishment Address

Fabrikstrasse 1E, Erlen Thurgau 8586, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

innotool & greminger ag (Owner Number: 10043239)

Owner / Operator Contact Address

Fabrikstrasse 1E, Erlen, CH-TG 8586, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-12-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-12
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-12-12
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-12
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-12-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-31
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2020-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-11-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-11-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-11-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-11-03
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2026-04-20
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2026-04-20
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2015-03-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-03-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-03-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-03-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-19
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-04-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-19
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-31
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-31
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-01-31
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-31
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-01-31
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-19
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-12-19
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-31

Official Correspondent

David Kreizer

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

innotool & greminger ag

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3012329926	UNITED ORTHOPEDIC CORPORATION	Hsinchu, TW
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
1526534	Sterigenics US, LLC	Lewis Center, OH, US
3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010314800. Last updated year: 2026. Please use registration number 3010314800 when referencing this establishment in official correspondence.