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510(k) Data Aggregation
K Number
K220261Device Name
NEST-C Interbody System
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2023-04-24
(448 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment.
The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Device Description
The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
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K Number
K182285Device Name
PK High Tibial Osteotomy Correction System
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2019-06-20
(301 days)
Product Code
KTW, JDW, KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia:
- Temporary fracture fixation
- Correction of deformity
- Osteotomy
- Bone union
- Bone reconstruction
- Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality
- Leg lengthening
Device Description
The PK High Tibial Osteotomy Correction System is a single-use external fixator which consisting of the following components: fixation plate, cortex pin and cancellous pin. Pins are available in various lengths and diameters according to practical requirements. These pins and other components are manufactured from 316L stainless steel (ASTM F138/ ISO 5832-1) and aluminum alloy. These devices are intended to be used in the tibia. Adjustment of the fixator is possible during the course of treatment. All components are provided sterile.
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K Number
K180230Device Name
NEST Interbody System
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2019-01-25
(364 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NEST Interbody System is indicated for interbody fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Device Description
The NEST Interbody System is an intervertebral body fusion cage which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow, rectangular implant consists of both solid and porous structures and serrations on the superior and inferior porous surfaces are for enhanced fixation.
The implant is designed to be used with supplemental fixation with cleared for use in the lumbosacral spine. The implant is offered in a variety of sizes to accommodate a variety of patients' anatomy. NEST is additively manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile.
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K Number
K180228Device Name
II-Type Intervertebral Spacer
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2019-01-11
(350 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The II-Type Intervertebral Spacer is intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Device Description
II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta markers, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft.
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K Number
K180226Device Name
TREND II Spinal Fixation System- STEP Series
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2018-07-25
(180 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
- Fractures
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Failed previous fusion (pseudarthrosis)
Device Description
TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.
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K Number
K161225Device Name
Paonan Armstrong Posterior Spinal Fixation System
Manufacturer
Paonan Biotech Co., Ltd.
Date Cleared
2017-08-11
(452 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Paonan Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Paonan" Armstrong Posterior System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacraliliac spine (T1-Sacrum/Tium) for the following indications:
- Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) degeneration of the disc confirmed by history and radies)
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment.
- Fractures
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Failed previous fusion (pseudarthrosis)
Device Description
"Paonan" Armstrong Posterior Spinal Fixation System includes pedicle screws, rods, cross connectors, and associated instruments. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.
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