4 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020