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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 30 of 65

Device	Model / Reference	Registries	Class	Status
Chung Weitlaner Retractor 3x4 Prongs Sharp Tips 25mm	5066-01	EUDAMEDFDA UDI	Class I	Active
Pituitary Rongeur with Teeth	1792	EUDAMEDFDA UDI	Class I	Active
Lombardi Femoral Tibial Spreader Small w/Lock Ratchet	1876-LR	EUDAMEDFDA UDI	Class I	Active
Arthrex Lobster Clamp	AR-18700-49	EUDAMEDFDA UDI	Class I	Active
Incavo Tibial Component Revision Osteotome Deep	3621-03	EUDAMEDFDA UDI	Class I	Active
T-Wrench	3620-04	EUDAMEDFDA UDI	Class I	Active
Richardson Type Soft Tissue Retractor 30mm Radiolucent	3231-30R	EUDAMEDFDA UDI	Class I	Active
Retractor ME-EC0004	ME-EC0004	EUDAMEDFDA UDI	Class I	Active
4.0mm Cannulated Hex Driver (A/O)	S0138	EUDAMEDFDA UDI	Class I	Active
Cheng Small Drive End	1425-11	EUDAMEDFDA UDI	Class I	Active
Screw Removal System Case Only	9017	EUDAMEDFDA UDI	Class I	Active
Table Clamp T-Handle Assembly	9120-10	EUDAMEDFDA UDI	Class I	Active
Cup Removal Starter Blade - 44mm	5205-44	EUDAMEDFDA UDI	Class I	Active
Pointed Fracture Reduction Clamp Ratchet Curved Right	3668-R	EUDAMEDFDA UDI	Class I	Active
Cup Removal Starter Instrument - 58mm	5200-58	EUDAMEDFDA UDI	Class I	Active
Cheng Trephine 21mm	1426-17	EUDAMED	Class I	Active
Duncan Metatarsal Clamp Large	1638	EUDAMEDFDA UDI	Class I	Active
Parsley Intraoperative Leg Length Cross Level	2615-03	EUDAMEDFDA UDI	Class I	Active
Garneti Flat Hip Cup Revision Punch	5275-02	EUDAMEDFDA UDI	Class I	Active
CupX Hip Cup Removal System 10 Sz Choice No Heads	5200-10	EUDAMEDFDA UDI	Class I	Active
Evans Glenoid Exposure Fukuda Retractor	5181	EUDAMEDFDA UDI	Class I	Active
Gerber Sub-Acromion Retractor Right	1640-01	EUDAMEDFDA UDI	Class I	Active
Case Tray Top Half	2022-TRAY-A	EUDAMEDFDA UDI	Class I	Active
Calcaneal Spreader Smooth Pads	1880	EUDAMEDFDA UDI	Class I	Active
Chen Shim 1mm	5217-01	EUDAMEDFDA UDI	Class I	Active
Chang Pin Clamp	1760-01	EUDAMEDFDA UDI	Class I	Active
Stanton Arthroscopic Leg Holder	4045	EUDAMEDFDA UDI	Class I	Active
Subscapularis Spreader Standard	T1005	EUDAMEDFDA UDI	Class I	Active
Lachiewicz-Hoover Patella Retractor	3235	EUDAMEDFDA UDI	Class I	Active
Wixson Baseplate 20" Baseplate Only	4050-BP	EUDAMEDFDA UDI	Class I	Active
Whelan Large Weitlaner Retractor 3x4 Blunt	1576-B	EUDAMEDFDA UDI	Class I	Active
Patella Cover Plate (Set of 4)	4230-00	EUDAMEDFDA UDI	Class I	Active
Cup Removal Starter Instrument - 80mm	5200-80	EUDAMEDFDA UDI	Class I	Active
Extended Cup Positioner 8mm	5475-10	EUDAMEDFDA UDI	Class I	Active
Screwdriver Sterilization Case	9003	EUDAMEDFDA UDI	Class I	Active
Tibial Standard Single Blade with Screw	3630-01S	EUDAMEDFDA UDI	Class I	Active
O'Brien Bone Clamp Small	1890-01	EUDAMEDFDA UDI	Class I	Active
Flexible Chisel Blade 8mm x 10.5"	S1236	EUDAMEDFDA UDI	Class I	Active
Cheng Trephine 15mm	1426-11	EUDAMED	Class I	Active
McGlamry Type Elevator 11mm	1643-11	EUDAMEDFDA UDI	Class I	Active
Cobra 2.5cm Retractor	C1019	EUDAMEDFDA UDI	Class I	Active
Velcro Long Strapes Package of 50 (Femur)	8100-P50	EUDAMEDFDA UDI	Class I	Active
Z Knee Retractor	4420-00	EUDAMEDFDA UDI	Class I	Active
Cup Removal Finish Instrument - 68mm	5201-68	EUDAMEDFDA UDI	Class I	Active
Wrench Universal Hip Cup Removal System 62mm-70mm	5208-04	EUDAMEDFDA UDI	Class I	Active
Velcro 2" x 31.5" Strap Orange Pkg of 10	8130-P	EUDAMEDFDA UDI	Class I	Active
Straight Screwdriver Bit	5195-02	EUDAMEDFDA UDI	Class I	Active
Wells Modified Lambotte Straight POA Osteotome	5276-01	EUDAMEDFDA UDI	Class I	Active
Screw Removal System Extractor Wrench	S0127-04	EUDAMEDFDA UDI	Class I	Active
Knee Retractor, Small	ME-EC0023	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.