Question 1

What types of medical devices does Medical Designs LLC manufacture?

Accepted Answer

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.

Question 2

Where is Medical Designs LLC based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Asfora Anterior Cervical Plate System	11-1106-FD27-3	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD63	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD42	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD20	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD16	FDA UDI	Class II	Active
Asfora Bullet Cage® System	11-9902-FD1	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	11-1106-FD1-28	FDA UDI	Class II	Active
BULLET Tapered Intervertebral Distractors and Drills	11-1814-FD2-16-1	FDA UDI	Class I	Active
Asfora Bullet Cage System	11-9905-FD35	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD37	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD47	FDA UDI	Class II	Active
Asfora Bullet Cage System	11-9905-FD23	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD9-2	FDA UDI	Class II	Active
Samba Screw System	11-1109-FD14	FDA UDI	Class II	Active
Asfora Anterior Cervical Plate System	K143688	FDA 510(k)FDA UDI	Class II	Active
Subdural Evacuating Port System, Model 11-9901	K002970	FDA 510(k)	Class II	Active
Asfora Anterior Cervical Plate System, One Level, 14mm Asfora Anterior Cervical Plate System, One Level, 16mm	K122497	FDA 510(k)	Class II	Active
SP-LINK™ System	K182352	FDA 510(k)	Class II	Active
Fixated Asfora BULLET CAGE® (FABC)	K181591	FDA 510(k)	Class II	Active
Samba Screw, 9mm Dia., 25mm Long, Sambia Screw, 9mm Dia., 30mm Long, Samba Screw 9mm Dia., 35mm Long, Samba Screw, 9mm D	K121148	FDA 510(k)	Class II	Active
Hand Drill, Model 11-9901-7	K022712	FDA 510(k)	Class II	Active
Asfora Bullet Cage	K112648	FDA 510(k)	Class II	Active
Subdural Evacuating Port System Cranial Access Kit (seps-Ca), (seps-Cal), (seps-Cand), Models 11-0401 Ca, 11-0401-Cal	K042359	FDA 510(k)	Class II	Active
Asfora Bullet Cage System	K090048	FDA 510(k)	Class II	Active

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