Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | OP-1 IMPLANT |
Classification Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Generic Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H010002 |
Supplement Number | S033 |
Date Received | 04/02/2012 |
Decision Date | 04/23/2012 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for modifications to the patient information brochure and summarized surgical technique. Op-i implant is indicated for use as an alternative toautograft in recalcitrant long bone nonunions where use of autografi is unfeasible and alternative treatments have failed. Op- i putty is indicated for the repair of symptomatic, poster-olateral (intertransverse) lumbar spine pseudoarthrosis in patients for whom autologous bone and/or bone marrow harvest are not feasible or are not expected to promote fusion and who have at least one of the following compromising factors: osteoporosis, diabetes or nicotine use. |
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