Cuff, Nerve
Regulation 882.5275
2510(k)s in 12 months (40 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in JXI
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 4 | 3 |
| Alafair Biosciences | 4 | 0 |
| Collagen Matrix, Inc. | 4 | 0 |
| Axogen Corporation | 3 | 0 |
| Biocircuit Technologies, Inc. | 3 | 0 |
| Cook Biotech Incorporated | 3 | 0 |
| Polyganics B.V., | 3 | 0 |
| Medovent GmbH | 2 | 0 |
| Salumedica, LLC | 2 | 0 |
| Auxilium Biotechnologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2023 | Baxter Healthcare Corporation GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair Open, Classified |
JXI | K983007 |
| Feb 7, 2020 | Integra LifeSciences Corp. NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieve Terminated |
JXI | K011168 |
| May 10, 2013 | Integra LifeSciences Corporation NeuraGen Nerve Guide
NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. Terminated |
JXI | K011168 |
| May 10, 2013 | Integra LifeSciences Corporation NeuraWrap Nerve Protector
NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Terminated |
JXI | K041620 K072207 |
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