The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Antegra System.
| Device ID | K063158 |
| 510k Number | K063158 |
| Device Name: | SYNTHES ANTEGRA SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-17 |
| Decision Date | 2006-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981041021370 | K063158 | 000 |
| H981041023030 | K063158 | 000 |
| H981041023070 | K063158 | 000 |
| H981041023110 | K063158 | 000 |
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| H981041031430 | K063158 | 000 |
| H981041031450 | K063158 | 000 |
| H981041031470 | K063158 | 000 |
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| H981041031510 | K063158 | 000 |
| H981041022990 | K063158 | 000 |
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| H981041021430 | K063158 | 000 |
| H981041021450 | K063158 | 000 |
| H981041021470 | K063158 | 000 |
| H981041021490 | K063158 | 000 |
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| H981041021530 | K063158 | 000 |
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| H981041022830 | K063158 | 000 |
| H981041022870 | K063158 | 000 |
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| H981041032790 | K063158 | 000 |
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| H981041032830 | K063158 | 000 |
| H981041032870 | K063158 | 000 |
| H981041032910 | K063158 | 000 |
| H981041032950 | K063158 | 000 |
| H981041032990 | K063158 | 000 |
| H981041033030 | K063158 | 000 |
| H981041033070 | K063158 | 000 |
| H981041033110 | K063158 | 000 |
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| H981042020360 | K063158 | 000 |