The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Biorci Screw.
| Device ID | K992396 |
| 510k Number | K992396 |
| Device Name: | BIORCI SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Demetrios Tsakonas |
| Correspondent | Demetrios Tsakonas SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 2000-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556608937 | K992396 | 000 |
| 03596010426291 | K992396 | 000 |
| 03596010426284 | K992396 | 000 |
| 03596010426277 | K992396 | 000 |
| 03596010426260 | K992396 | 000 |
| 03596010426253 | K992396 | 000 |
| 03596010426246 | K992396 | 000 |
| 03596010426239 | K992396 | 000 |
| 03596010426222 | K992396 | 000 |
| 03596010426215 | K992396 | 000 |
| 03596010426208 | K992396 | 000 |
| 03596010426192 | K992396 | 000 |
| 03596010426185 | K992396 | 000 |
| 03596010395580 | K992396 | 000 |
| 03596010426307 | K992396 | 000 |
| 03596010426314 | K992396 | 000 |
| 00885556608920 | K992396 | 000 |
| 00885556608913 | K992396 | 000 |
| 00885556608906 | K992396 | 000 |
| 00885556608890 | K992396 | 000 |
| 00885556608883 | K992396 | 000 |
| 00885556608876 | K992396 | 000 |
| 00885556608869 | K992396 | 000 |
| 00885556608852 | K992396 | 000 |
| 00885556608845 | K992396 | 000 |
| 00885556608838 | K992396 | 000 |
| 00885556568903 | K992396 | 000 |
| 00885554008975 | K992396 | 000 |
| 03596010426321 | K992396 | 000 |
| 03596010252821 | K992396 | 000 |