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Innomed, Inc.

United States·US-MF-000014761

Last updated September 17, 2026

What Innomed, Inc. makes

Innomed, Inc. manufactures reusable orthopaedic surgical instruments, including implant inserters and extractors, hand-held retractors, drill guides, and external distractors. Their portfolio also covers specialized tools like acetabular reamers, leg procedure positioners, and sterilization/disinfection containers designed for surgical environments.

The company’s devices are classified under FDA categories Class I and Class II, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Innomed, Inc. manufacture?

Innomed, Inc. specializes in reusable orthopaedic surgical instruments. Their product range includes tools like implant inserters and extractors, hand-held retractors, surgical drill guides, external distractors, acetabular reamers, leg procedure positioners, and sterilization/disinfection containers. These devices are designed to support orthopaedic surgeries and ensure precision in surgical environments.

Where is Innomed, Inc. based?

Innomed, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under FDA guidelines and may influence device classification and reporting requirements.

Which regulatory registries list Innomed, Inc.’s devices?

Innomed, Inc.’s devices are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with European and U.S. medical device regulations, respectively.

How are Innomed, Inc.’s devices classified under FDA regulations?

Innomed, Inc.’s devices fall under FDA Class I and Class II classifications. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification determines regulatory oversight and submission requirements for each device.

Why are some of Innomed’s devices reusable, and what does that mean for their classification?

Innomed, Inc. manufactures reusable devices like implant inserters, retractors, and sterilization containers, which are designed for repeated use after proper cleaning and sterilization. Reusability can influence classification—some reusable orthopaedic tools may fall under Class II due to factors like surgical precision, risk of contamination, or potential patient harm if misused, requiring stricter controls than non-reusable alternatives.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 103, Estus Drive, Savannah, United States
Website: www.innomed.net/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 912 236 0000
PRRC Contact: Aaron Ingram
EUDAMED SRN: US-MF-000014761
FDA FEI Number: 1833053
DUNS Number: 878427491

Catalogue (3242)

Page 27 of 65

Device	Model / Reference	Registries	Class	Status
Grant TKA Anatomic Bone File 2 Degrees Right	6906-03	EUDAMEDFDA UDI	Class I	Active
Harvey Lumbar Bone Graft Sled Assembly	5083-00	EUDAMEDFDA UDI	Class I	Active
Delrin Block for 3920	3920-05	EUDAMEDFDA UDI	Class I	Active
Browner MIS Bone Hook Clamp	1379	EUDAMEDFDA UDI	Class I	Active
Needle Holder/Scissors 6.5" TC Tip	3065	EUDAMEDFDA UDI	Class I	Active
Instrument Case Tray	9007-TRAY	EUDAMEDFDA UDI	Class I	Active
Extra Rongeur 12mm x 16mm	1771-03	EUDAMEDFDA UDI	Class I	Active
Lipof Proximal Tibial Rasp Handle	6904-01	EUDAMEDFDA UDI	Class I	Active
Shell Extraction Handle Standard	804-06-078	EUDAMED	Class I	Active
Coated Femoral Tibial Spreader Small	1850-01	EUDAMEDFDA UDI	Class I	Active
Adaptor Foot for Nicholson Shoulder Extractor	3670-10	EUDAMEDFDA UDI	Class I	Active
Silicone Brackets for 9003 Case	9003-BR	EUDAMEDFDA UDI	Class I	Active
Radial Osteotome 5" x 14mm diameter	S1134	EUDAMEDFDA UDI	Class I	Active
Roberts Pin Bender Medium	2113-02	EUDAMEDFDA UDI	Class I	Active
Unger Offset Narrow Hohmann with One Tip Left	3009-L	EUDAMEDFDA UDI	Class I	Active
Large Exposure Self Retaining Retractor	1581-01	EUDAMEDFDA UDI	Class I	Active
Thornberry Large Patient Hip Positioner Back Support	4160-01	EUDAMEDFDA UDI	Class I	Active
Starter/Finisher 80mm Blade Contour Template	5200-80G	EUDAMEDFDA UDI	Class I	Active
Extraction Push Rod	2027-12B	EUDAMEDFDA UDI	Class I	Active
7" Intraarticular Tissue Grasper/Rongeur Small Grip Handle	1790-03-SG	EUDAMEDFDA UDI	Class I	Active
Pin Driver for 2.5mm Pin (Tornier)	1206-T	EUDAMEDFDA UDI	Class I	Active
Mobile Ortholucent Arm	7428-01A	EUDAMEDFDA UDI	Class I	Active
Hibbs Retractor Medium	6235	EUDAMEDFDA UDI	Class I	Active
Ortho Mini Gouge 5mm	1168-5	EUDAMEDFDA UDI	Class I	Active
Hip Cup Wrench Finish Blade - 62mm Exchange	5206W-62	EUDAMEDFDA UDI	Class I	Active
PCL Retractor Wide Prongs	2825	EUDAMEDFDA UDI	Class I	Active
Bent Hohmann	SYK-7110	EUDAMEDFDA UDI	Class I	Active
Wide PCL Retractor	3520	EUDAMEDFDA UDI	Class I	Active
Jackson Ankle Distraction Set	0009-00	EUDAMEDFDA UDI	Class I	Active
Cheng Case Tray	1425-CASET	EUDAMEDFDA UDI	Class I	Active
Nordt Micro Fracture 40 Degree Awl	8025-02	EUDAMEDFDA UDI	Class I	Active
Gerber Sub-Acromion Retractor Right Modified	1641-01	EUDAMED	Class I	Active
Articulating Arm	5468	EUDAMEDFDA UDI	Class I	Active
Modified Fat Pad Retractor Small	3217-S	EUDAMEDFDA UDI	Class I	Active
Flexible Chisel Blade 8mm x 11.5"	S1237	EUDAMEDFDA UDI	Class I	Active
Bacastow Femoral Cement Osteotome	5234	EUDAMEDFDA UDI	Class I	Active
Ortho Mini Gouge 4mm	1168-4	EUDAMEDFDA UDI	Class I	Active
Parsley Intraopertive Leg Length Post	2615-S	EUDAMEDFDA UDI	Class I	Active
Starter/Finisher 72mm Blade Contour Template	5200-72G	EUDAMEDFDA UDI	Class I	Active
10" Bone Impacting/Grafting Forceps 1/4" dia	5050-03	EUDAMEDFDA UDI	Class I	Active
Unger Total Knee Revision Osteotome Starter Narrow	4705	EUDAMEDFDA UDI	Class I	Active
5" Standard Blade with T-Handle	7450-05T	EUDAMEDFDA UDI	Class I	Active
Glenoid Retractor Short Pronged, Wide	1902-W	EUDAMEDFDA UDI	Class I	Active
Cup Removal Starter Instrument - 42mm	5200-42	EUDAMEDFDA UDI	Class I	Active
Stulberg Hip Post Replacement Pads Case of 12	4150-PD12	EUDAMEDFDA UDI	Class I	Active
Stulberg Leg Positioner Extra Long 30”	2620-XLNG	EUDAMEDFDA UDI	Class I	Active
Anterior Watson Jones Awl Right	6301-R	EUDAMEDFDA UDI	Class I	Active
Lawrence Revision Knee Gap Bal Tensioner Medial Right	1896-01R	EUDAMEDFDA UDI	Class I	Active
Wrench Drive Start Cup Cutter - 60mm	5208-60	EUDAMEDFDA UDI	Class I	Active
Long Thread Adapting Screw	3980-03	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MediMark Europe Sarl. FR

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Innomed, Inc. has one FDA recall record initiated on March 7, 2024, which is marked as completed. The recall involved a 54 MM finisher blade that was incorrectly attached to the shaft of the CupX handle instead of the intended 54 MM starter blade.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 7, 2024	Z-1753-2024	—	completed	54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.