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510(k) Data Aggregation
K Number
K132287Device Name
JAZZ SYSTEM
Manufacturer
HOGAN LOVELLS US LLP
Date Cleared
2013-09-25
(64 days)
Product Code
OWI
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
HOGAN LOVELLS US LLP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in conjunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.
The JAZZ System is intended to be used with the Implanet Spine System.
Device Description
The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.
The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.
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K Number
K120564Device Name
CALYPSO SYSTEM
Manufacturer
HOGAN LOVELLS US LLP
Date Cleared
2012-07-16
(143 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
HOGAN LOVELLS US LLP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.
Device Description
The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.
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