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510(k) Data Aggregation
K Number
K230325Device Name
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Manufacturer
Greens Surgicals Pvt. Ltd.
Date Cleared
2024-10-10
(612 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Greens Surgicals Pvt. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: · Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (e.g., fracture or dislocation) - · Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) - Tumor - · Spinal stenosis - · Pseudarthrosis - · Failed previous fusion Paediatric Use: When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions: - · Spondylolisthesis - · Spondylolysis - Fracture caused by tumor and/or trauma. Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Device Description
The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods are fabricated from Titanium alloy. These implants are supplied non-sterile; the products have to be sterilized prior to use.
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K Number
K163383Device Name
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
Manufacturer
GREENS SURGICALS PVT. LTD.
Date Cleared
2017-04-19
(139 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
GREENS SURGICALS PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System are provided non-sterile.
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis 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).
GREENS Brand of DHS/ Dynamic Condylar Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
Device Description
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel And Titanium.
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, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T- Plates, , Anatomical Plates, Clavicle Hook Plates.
These all are mainly divided into
- Large Fragment Plates
- Small Fragment Plates ●
- Mini Fragment Plates
- Hip Plates (DHS and Dynamic Condylar Plate)
The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.
The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm
The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm.
These implants are supplied non-sterile, the products have to be sterilized prior to use.
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