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MEDICAL DESIGNS LLC

Last updated May 27, 2026

What MEDICAL DESIGNS LLC makes

Medical Designs LLC manufactures orthopaedic fixation devices, including non-bioabsorbable spinal plates, sacroiliac joint fixation implants, and metallic interbody fusion cages for spinal stabilization. Their portfolio also includes reusable surgical tools like cannulated drill bits and implant inserters, as well as orthopaedic screws and arthrodesis kits for joint stabilization. Specific products include anterior cervical plate systems, tapered intervertebral distractors, and a sacroiliac joint fixation system.

The company’s devices are regulated under the FDA’s Class I and Class II classifications, with many authorised through the 510(k) and Unique Device Identification (UDI) pathways. These products are listed in the FDA’s regulatory databases, and the manufacturer operates from 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 Medical Designs LLC manufacture?

Medical Designs LLC manufactures orthopaedic fixation devices such as non-bioabsorbable spinal plates, sacroiliac joint fixation implants, metallic interbody fusion cages, and orthopaedic bone screws. The company also produces reusable surgical tools including cannulated drill bits and implant inserters/extractors, along with arthrodesis kits for joint stabilization, based solely on the device categories and examples provided in the data.

Where is Medical Designs LLC based?

Medical Designs LLC is based in the United States, as explicitly stated in the COUNTRY field of the device data, which identifies the company's location as US.

In which regulatory registries are Medical Designs LLC's devices listed?

Medical Designs LLC's devices are listed in the FDA's 510(k) and Unique Device Identification (UDI) registries, as indicated by the LISTED IN field which specifies fda_510k and fda_udi as the regulatory databases where the company's devices appear.

How are Medical Designs LLC's devices classified under regulatory frameworks?

Medical Designs LLC's devices are classified as Class I and Class II under the FDA's regulatory system, as stated in the DEVICE CLASSES field, which identifies these two classification levels as applicable to the company's products.

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

Information

Country: US
Address: —
Website: medicaldesignsllc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 605-275-1032
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 003815548

Catalogue (174)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Asfora Bullet Cage System	11-9905-FD24	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD8	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD45	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD2	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD17	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-2-08-2	FDA UDI	Class I	Active
Asfora Anterior Cervical Plate System	11-1106-FD2-32	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD7-14	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD3-63	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD12	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD3-51	FDA UDI	Class II	Active
Dakota Knife Blade®	11-0204-FD2	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD32	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD16	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-FD1-06	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD19	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-2-05	FDA UDI	Class I	Active
Asfora Anterior Cervical Plate System	11-1106-FD1-32	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD16	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD59	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD7-3	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD29	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD10	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD3-72	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD4-94	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD43	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD4-90	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD41	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD7	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-2-06-2	FDA UDI	Class I	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-2-14-2	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD49	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-FD2-12-1	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD138	FDA UDI	Class II	Active
SAMBA® Screw System	11-1109-FD3	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD27-2	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD8-14	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD46	FDA UDI	Class II	Active
SAMBA Screw System	11-1109-FD2	FDA UDI	Class II	Active
Asfora Bullet Cage® System	11-9902-FD9	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD28	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD31-1	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-2-12-2	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD34	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD22	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD5	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD9-16	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD3-66	FDA UDI	Class II	Active
SAMBA® Screw System	11-1109-FD4	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD1-30	FDA UDI	Class II	Active

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