The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Flap Tube Clamp.
| Device ID | K992000 |
| 510k Number | K992000 |
| Device Name: | SYNTHES CRANIAL FLAP TUBE CLAMP |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 1999-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98046010701S0 | K992000 | 000 |
| H98046000101S0 | K992000 | 000 |
| H9804600020 | K992000 | 000 |
| H98046000201S0 | K992000 | 000 |
| H9804600030 | K992000 | 000 |
| H98046000301S0 | K992000 | 000 |
| H9804600080 | K992000 | 000 |
| H98046000801S0 | K992000 | 000 |
| H9804600090 | K992000 | 000 |
| H98046000901S0 | K992000 | 000 |
| H9804600100 | K992000 | 000 |
| H98046001001S0 | K992000 | 000 |
| H9804601000 | K992000 | 000 |
| H98046010001S0 | K992000 | 000 |
| H9804601070 | K992000 | 000 |
| H9804600010 | K992000 | 000 |