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510(k) Data Aggregation
K Number
K242457Device Name
EARP Interbody System
Manufacturer
Retropsoas Technologies, LLC
Date Cleared
2024-10-07
(49 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Retropsoas Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone to facilitate fusion and are implanted via a posterolateral approach.
Device Description
The EARP Interbody System is an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK OPTIMA® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radio-graphic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
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K Number
K241917Device Name
EARP Nerve Cuff Electrode
Manufacturer
Retropsoas Technologies, LLC
Date Cleared
2024-07-31
(30 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
Retropsoas Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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