Question 1

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

Accepted Answer

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.

Question 2

Where is Innomed, Inc. based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
MIS Utility Knee Retractor	3220-03	EUDAMEDFDA UDI	Class I	Active
Capsule Retractor, 2 Prong	SYK-T1008	EUDAMEDFDA UDI	Class I	Active
Modular Impactor Set Handle	5370-H	EUDAMEDFDA UDI	Class I	Active
Cup Removal Starter Instrument - 44mm	5200-44	EUDAMEDFDA UDI	Class I	Active
100mm Extension Pin (Single)	1250-S	EUDAMEDFDA UDI	Class I	Active
Screwdriver Handle	5195-01	EUDAMEDFDA UDI	Class I	Active
Mod Kolbel Self-Retaining Glenoid Retractor no Blades	T1050-01	EUDAMEDFDA UDI	Class I	Active
Meyerding Spreader	6244	EUDAMEDFDA UDI	Class I	Active
Unger Total Knee Revision Osteotome Finisher	4710	EUDAMEDFDA UDI	Class I	Active
Anterior Femoral Punch Left	8626-L	EUDAMEDFDA UDI	Class I	Active
RR2056-01 Osteotome	2056-01	EUDAMED	Class I	Active
Multi-Adjustment Positioner Clamp Screw Assembly	4030-04	EUDAMEDFDA UDI	Class I	Active
Wide Rake Retractor Deep Sharp	6051	EUDAMEDFDA UDI	Class I	Active
Unger Femoral Neck Elevator	3006	EUDAMEDFDA UDI	Class I	Active
Right Interior Posterior Acetabular Retracto	C1008	EUDAMEDFDA UDI	Class I	Active
Adjustable Drill Guide Assembly SS	AR-8717AG	EUDAMEDFDA UDI	Class I	Active
Nordt Micro Fracture Bent Stirrup Scraper	8025-04	EUDAMEDFDA UDI	Class I	Active
Ortholoc Pin Puller	18770140	EUDAMEDFDA UDI	Class I	Active
Storage Case Lid for ABLE	6161-LID	EUDAMEDFDA UDI	Class I	Active
Dorr Femoral Neck Elevator Wide	D6111	EUDAMEDFDA UDI	Class I	Active
Sarraf Forward Toothed Curette	5174-F	EUDAMEDFDA UDI	Class I	Active
Tibial Hex Wrench	3630-HW	EUDAMEDFDA UDI	Class I	Active
Lawton Distal Radius Assistant Free Mini Blade Short	1578-02	EUDAMEDFDA UDI	Class I	Active
Velcro 2" x 24" Strap Black Pkg of 10	8129-P	EUDAMED	Class I	Active
Wide, Long Handled Fukuda Type Retractor	1940-H	EUDAMEDFDA UDI	Class I	Active
McKinley Foraminal Probe Large 4.5mm/.156"	5001-L	EUDAMED	Class I	Active
Taylor Retractor Large	6330-02	EUDAMEDFDA UDI	Class I	Active
Slavitt Phalangeal Forceps	1163	EUDAMEDFDA UDI	Class I	Active
Engh Cement Scraper Left	4920-02	EUDAMEDFDA UDI	Class I	Active
Lombardi Hip Cup Liner/Shell Extractor w/Slaphammer	3638-00	EUDAMEDFDA UDI	Class I	Active
Hip Cup Wrench Finish Blade - 52mm Exchange	5206W-52	EUDAMEDFDA UDI	Class I	Active
Retractor Springs Set	8211-00	EUDAMEDFDA UDI	Class I	Active
Powers Femoral Sound 10mm	4189-10	EUDAMEDFDA UDI	Class I	Active
Sarraf TiN Coated Angled Forceps	5041	EUDAMEDFDA UDI	Class I	Active
Kirschenbaum Foot Positioner Short	2591	EUDAMEDFDA UDI	Class I	Active
Pin Puller, T Mini	109565	EUDAMEDFDA UDI	Class I	Active
Calcaneal Distractor Large Closed Arms with Speedlock	4216-LS	EUDAMEDFDA UDI	Class I	Active
Stulberg Hip Positioner Case Bottom	9002-B	EUDAMEDFDA UDI	Class I	Active
Brown/Gorski 8mm Tray Hook without Slaphammer	3655-01	EUDAMEDFDA UDI	Class I	Active
Charnley Blade 3.5" Rounded Assistant Free	7445-04	EUDAMEDFDA UDI	Class I	Active
APC Proximal Femoral Elevator Small	3421-01	EUDAMEDFDA UDI	Class I	Active
Finger Curette	5351	EUDAMEDFDA UDI	Class I	Active
Ligament Release Cutter	7803-001	EUDAMEDFDA UDI	Class I	Active
Cobra Retractor Narrow Extra Long	6120-04	EUDAMEDFDA UDI	Class I	Active
Manzary Proximal Tibial Stabilizing Knee Retractor	4531	EUDAMEDFDA UDI	Class I	Active
Lighted Standard Cobra Retractor Set	6130-L-01	EUDAMEDFDA UDI	Class I	Active
Stulberg Table Attachment	4150-TA	EUDAMEDFDA UDI	Class I	Active
Hand/Finger Positioner	1134	EUDAMEDFDA UDI	Class I	Active
Foster Tibial Prosthesis Disimpactor Set	1213-00	EUDAMEDFDA UDI	Class I	Active
Periarticular Reduction Forceps Large	1857	EUDAMEDFDA UDI	Class I	Active

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