Sintea Biotech, Inc. · Class II · Cleared Dec 17, 2004
| K-number | K043355 |
| Device name | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X |
| Applicant | Sintea Biotech, Inc. |
| Product code | KWP |
| Device class | Class II |
| Decision date | Dec 17, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 888.3050 |
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