The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 2.4mm Cortex Screw, Self-tapping.
| Device ID | K002271 |
| 510k Number | K002271 |
| Device Name: | 2.4MM CORTEX SCREW, SELF-TAPPING |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2000-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982262776 | K002271 | 000 |
| H6792016220 | K002271 | 000 |
| H6792016240 | K002271 | 000 |
| H6792016260 | K002271 | 000 |
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| H6792016790 | K002271 | 000 |
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| H6792016810 | K002271 | 000 |
| H6792016830 | K002271 | 000 |
| H6792016850 | K002271 | 000 |
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| 10886982262974 | K002271 | 000 |
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| 10886982263025 | K002271 | 000 |
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| H6792016120 | K002271 | 000 |
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| H6792017660 | K002271 | 000 |
| H6792017680 | K002271 | 000 |
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| H6792017760 | K002271 | 000 |
| H6792017780 | K002271 | 000 |
| H6792017800 | K002271 | 000 |
| H6792017820 | K002271 | 000 |
| H6792017840 | K002271 | 000 |
| H6792017860 | K002271 | 000 |
| H6792017880 | K002271 | 000 |
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| H6792016930 | K002271 | 000 |
| H6792016940 | K002271 | 000 |
| H6792016950 | K002271 | 000 |
| H6792016960 | K002271 | 000 |
| H6792016970 | K002271 | 000 |
| H6792016980 | K002271 | 000 |
| H6792016990 | K002271 | 000 |
| H6792017000 | K002271 | 000 |
| H6792017560 | K002271 | 000 |
| H6792017900 | K002271 | 000 |