The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Bone Plate And Screw Implants, Model#'s 222020-248120, 240050-240980, 241130-246620, 4240420.
| Device ID | K983495 |
| 510k Number | K983495 |
| Device Name: | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Contact | Ted Y Shi |
| Correspondent | Ted Y Shi SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-05 |
| Decision Date | 1998-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719864661369 | K983495 | 000 |
| 04719864684467 | K983495 | 000 |
| 04719864661208 | K983495 | 000 |
| 04719864661215 | K983495 | 000 |
| 04719864661222 | K983495 | 000 |
| 04719864661239 | K983495 | 000 |
| 04719864661246 | K983495 | 000 |
| 04719864661253 | K983495 | 000 |
| 04719864661260 | K983495 | 000 |
| 04719864661277 | K983495 | 000 |
| 04719864661284 | K983495 | 000 |
| 04719864661291 | K983495 | 000 |
| 04719864661307 | K983495 | 000 |
| 04719864661314 | K983495 | 000 |
| 04719864661321 | K983495 | 000 |
| 04719864661338 | K983495 | 000 |
| 04719864661345 | K983495 | 000 |
| 04719864661352 | K983495 | 000 |
| 04719864684672 | K983495 | 000 |