Is this your brand? Sign in to claim ownership.

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 25 of 65

Device	Model / Reference	Registries	Class	Status
Levy Wide Deltoid Retractor	1672	EUDAMEDFDA UDI	Class I	Active
Hintermann Compressor/Distractor	144-00031	EUDAMEDFDA UDI	Class I	Active
Cone Ring Curette 35 Degree Angle #1 (3mm)	5156	EUDAMEDFDA UDI	Class I	Active
Joint Calcaneal Small Bone Compressor/Distractor	4865-LS	EUDAMEDFDA UDI	Class I	Active
Tissue Protector for Femur Finder	6010	EUDAMEDFDA UDI	Class I	Active
Beard Self Retaining Retractor Large	5834-02	EUDAMEDFDA UDI	Class I	Active
Meyerding Type Retractor 75 x 15mm with Contour Grip	6242-01	EUDAMEDFDA UDI	Class I	Active
Positioning Board 1 Piece	4095-PB	EUDAMEDFDA UDI	Class I	Active
Cup Removal Finish Blade - 68mm	5206-68	EUDAMEDFDA UDI	Class I	Active
Cheng Trephine 17mm	1426-13	EUDAMED	Class I	Active
Bozeman Cement Trimmer	5245	EUDAMEDFDA UDI	Class I	Active
Whelan Curved Chisel Guide	5302-01	EUDAMEDFDA UDI	Class I	Active
Mazzara Rongeur 7x16mm Bite with Pistol Grip Handle	1765-02	EUDAMEDFDA UDI	Class I	Active
Rogozinski Locking Needle Driver/Scissors Large	3084	EUDAMEDFDA UDI	Class I	Active
Eickmann Case Tray	5470-CASE-01	EUDAMEDFDA UDI	Class I	Active
Darrach Large	SYK-1965	EUDAMEDFDA UDI	Class I	Active
Curved Anterior Retractor Wide	7804-03	EUDAMEDFDA UDI	Class I	Active
Bone Holding Elbow Fracture Reduction Clamp Right	1756-R	EUDAMEDFDA UDI	Class I	Active
45 Degree Knee Retractor Medium	6290-00-077	EUDAMEDFDA UDI	Class I	Active
9003 Case Lid	9003-LID	EUDAMEDFDA UDI	Class I	Active
Lubahn Carpal Corkscrew Standard	1191	EUDAMEDFDA UDI	Class I	Active
Double Prong Double Bent Hohmann 3"	6220	EUDAMEDFDA UDI	Class I	Active
Lee Pin Adjustment Guide 1.4mm/2.0mm	3013-02	EUDAMEDFDA UDI	Class I	Active
Anterior Watson Jones Deep Hohmann Retractor	6306	EUDAMEDFDA UDI	Class I	Active
Lombardi Long Taper Cleaner 11.4 x 13.4	8034-01	EUDAMEDFDA UDI	Class I	Active
Extended Drill Sleeve 4.5/4.0mm	3014-04	EUDAMEDFDA UDI	Class I	Active
Hip Cup Wrench Starter Blade - 58mm Exchange	5205W-58	EUDAMEDFDA UDI	Class I	Active
Chandran Cannulated Dilator/Sizer for Reconstruction	8204	EUDAMEDFDA UDI	Class I	Active
Lachiewicz Cement Prosthesis Osteotome 20" W Exchange	3700-07-E	EUDAMEDFDA UDI	Class I	Active
Hohmann Retractor Ortholucent Square Tip 16mm	4558-R	EUDAMEDFDA UDI	Class I	Active
4.2mm Trephine (A/O)	S0123	EUDAMEDFDA UDI	Class I	Active
Acetabular Liner Removal Osteotome Set	4085-00	EUDAMEDFDA UDI	Class I	Active
Carpal Tunnel Release Blades (Pack of 2)	1124-02	EUDAMEDFDA UDI	Class I	Active
Mazzara Rongeur 5x14mm Bite with Pistol Grip Handle	1765-01	EUDAMEDFDA UDI	Class I	Active
Rivero Extra Grip Femoral Head Remover (Corp)	3706-M	EUDAMEDFDA UDI	Class I	Active
Dodson Distal Radius Retractor Assembly with 2 Mini Hohmanns	1838-00	EUDAMEDFDA UDI	Class I	Active
Slotted Mallet	S7585	EUDAMEDFDA UDI	Class I	Active
Durham Leg Positioner Stabilizer	4105-02	EUDAMEDFDA UDI	Class I	Active
Gelpi	SYK-4180	EUDAMEDFDA UDI	Class I	Active
Stulberg 10" Post with Pads, Slider & Table Assembly	4150-10D	EUDAMEDFDA UDI	Class I	Active
Angled Hip Capsule Clamp	1767	EUDAMEDFDA UDI	Class I	Active
Sorrells Hip Removal Arthroplasty Set	7318-00	EUDAMEDFDA UDI	Class I	Active
Thornberry Hip Post 18" Post with Fixed Lower Arm	4160-18	EUDAMEDFDA UDI	Class I	Active
Extraction Screwdriver for 2.7/3.5/4.0mm	2022-06	EUDAMEDFDA UDI	Class I	Active
Sarraf Cement Trimmer	5212	EUDAMEDFDA UDI	Class I	Active
Rake Retractor Small 3 Prong with Ergonomic Handle	4839	EUDAMEDFDA UDI	Class I	Active
Redler Percutaneous Pin Clamp .045	1810-45	EUDAMEDFDA UDI	Class I	Active
Flexible Chisel Blade 8mm x 5.5"	S1227	EUDAMEDFDA UDI	Class I	Active
Wixson Anterior Suspension Hook System	6245-00	EUDAMEDFDA UDI	Class I	Active
T-Handle Femoral Canal Finder Smooth	4990-03	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MediMark Europe Sarl. FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.