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NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only.

The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. Throughout the submission there is a mention of NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System that represents the range of products covered under this 510(k) submission. The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are subdivided into the following categories: | S. No. | Category | Types | |--------|-----------------------|-----------------------------------------------------------------| | 01 | Mini, Small and Large | Volar Plates, T-Shaped, Angled Plates,<br>Reconstruction plates | | 02 | Dynamic compression | Small, Narrow, Lengthening | | 03 | Hip Plate | Dynamic Hip Screw Plates | | 04 | Bone Screws | Locking and Non-Locking Version | Generally, there are the following types of bone plates used with cortical (cortex), cancellous, and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy. | S. No. | Type | Subtype | |--------|-----------------------------------|-----------------------------------------------------------------| | 01 | Mini, Small and Large<br>Fragment | Volar Plates, T-Shaped, Angled Plates,<br>Reconstruction plates | | 02 | Dynamic compression | Small, Narrow, Lengthening Narrow, Broad Plates | | 03 | Hip Plate | Dynamic Hip Screw Plates | NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The plates and screws are fabricated from Stainless Steel and Titanium. The implants are supplied non-sterile and should be steam-sterilized prior to use. The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, and the ankle. The plate implants are available in models such as Reconstruction Plates, T- Plates, , Anatomical Plates, and Clavicle Plates. These all are mainly divided into the following: - . Large Fragment Plates - Small Fragment Plates - Hip Plates (DHS Plate) The thickness of the plates varies from 1.3mm to 6mm; and the nomber of the holes varies from 2 to 20. The Locking screw implants are in corresponding diameter ranges from 2.7mm, and 4.9 mm diameters with lengths varying as per the requirements and lengths of 10mm to 90 mm The Non-locking cortical screw implants are in 3.5mm diameter and length range from 10mm to 80mm. The Non-locking cancellous screws are in 6.5mm diameter and length range from 30mm to 120mm The Non-locking cannulated cancellous screws are in 4.0mm diameter and length range from 10mm to 72mm The Lag Screw is of 12.5mm Diameter and length from 50mm to 120mm