Question 1

What types of medical devices does Symmetry Medical manufacture?

Accepted Answer

Symmetry Medical produces a diverse portfolio of surgical and orthopaedic equipment. Their primary offerings include reusable fluted surgical drill bits, bone holding forceps, and surgical suction cannulae. Additionally, they manufacture orthopaedic implant inserters and extractors, single-use bone-resection reamers, surgical instrument handles, and external orthopaedic distractors, as these are the categories identified in their product documentation.

Question 2

Where is Symmetry Medical based?

Accepted Answer

Symmetry Medical is based in the United States. This location information is provided as part of the company's official profile data, which identifies the country of origin for their manufacturing operations.

Question 3

How are the devices from Symmetry Medical classified?

Accepted Answer

The devices manufactured by Symmetry Medical are classified as Class I and Class II medical devices. These classifications are determined based on the regulatory requirements for the specific types of surgical instruments and orthopaedic tools the company produces.

Question 4

Which regulatory registries list Symmetry Medical devices?

Accepted Answer

Devices from Symmetry Medical are listed in the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system. These registries are used to track and document the regulatory status and identification information for the medical devices the company brings to market.

Device	Model / Reference	Registries	Class	Status
Reduction Forcep w/Points	214213568	FDA UDI	Class I	Active
3.2MM Drill Bit	11-099-000	FDA UDI	Class I	Active
Suction Tube, 11 Fr, 90° angle, 118mm shaft (with stylet)	74-756-000	FDA UDI	Class II	Active
Reduction Forcep w/Serrated Jaw	74-285-000	FDA UDI	Class I	Active
Cutting Pliers	74-388-000	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	00-4361-073-20	FDA UDI	Class I	Active
Zimmer Trabecular Metal Tm Reverse Shoulder System Instrumentation	00-4361-070-00	FDA UDI	Class I	Active
Smith & Nephew OFFSET DRIVER DUAL CONNECTION ASSY	075021SN	FDA UDI	Class I	Active
Adapter Shaft AO Small To Hudson	09-159-000	FDA UDI	Class I	Active
Lamina Spreader	74-018-000	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	00-4361-081-00	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation Tecomet Reame	00-4361-084-00	FDA UDI	Class I	Active
K-Wire Towel Clamp	74-372-000	FDA UDI	Class I	Active
Smith & Nephew 3/8 UNC CUP IMPACTOR SN - CUP IMPACTOR PACK	SN087100	FDA UDI	Class I	Active
Smith & Nephew TIP INSERT - OFFSET CUP IMPACTOR	871001	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	47-4361-083-00	FDA UDI	Class I	Active
GLOBAL UNITE™ Short Stem Instrumentation	210005110	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	00-4361-073-25	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	00-4361-073-15	FDA UDI	Class I	Active
Large Fragment Bone Clamp	74-294-000	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	00-4361-073-30	FDA UDI	Class I	Active
Zimmer® Trabecular Metaltm Reverse Shoulder System Instrumentation	47-4361-085-00	FDA UDI	Class I	Active
Proximal Tibia Clamp	74-383-000	FDA UDI	Class I	Active
Smith & Nephew ANTEVERSION GUIDE - OFFSET CUP IMPACTOR	871002	FDA UDI	Class I	Active
Suction Tube, 11 Fr, 90° angle, 177mm shaft (with stylet)	74-755-000	FDA UDI	Class II	Active
Case 2 Complete	87-1178	FDA UDI	Class II	Active
Polyvac Surgical Instrument Delivery System	K012105	FDA 510(k)	Class II	Active
Flashpak	K113776	FDA 510(k)	Class II	Active
14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use	K122263	FDA 510(k)	Class II	Active

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