The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Acufex Screw Cannula.
| Device ID | K972599 |
| 510k Number | K972599 |
| Device Name: | ACUFEX SCREW CANNULA |
| 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 | 1997-07-14 |
| Decision Date | 1997-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554012644 | K972599 | 000 |
| 03596010375100 | K972599 | 000 |
| 03596010375094 | K972599 | 000 |
| 03596010375087 | K972599 | 000 |
| 03596010375070 | K972599 | 000 |
| 03596010375063 | K972599 | 000 |
| 03596010375056 | K972599 | 000 |
| 03596010375049 | K972599 | 000 |
| 03596010375032 | K972599 | 000 |
| 03596010375025 | K972599 | 000 |
| 03596010375018 | K972599 | 000 |
| 03596010375001 | K972599 | 000 |
| 03596010374998 | K972599 | 000 |
| 03596010374981 | K972599 | 000 |
| 03596010374974 | K972599 | 000 |
| 03596010374967 | K972599 | 000 |
| 03596010374950 | K972599 | 000 |
| 03596010375117 | K972599 | 000 |
| 03596010510693 | K972599 | 000 |
| 00885554012170 | K972599 | 000 |
| 00885554012002 | K972599 | 000 |
| 00885554011753 | K972599 | 000 |
| 00885554011425 | K972599 | 000 |
| 00885554011395 | K972599 | 000 |
| 00885554010978 | K972599 | 000 |
| 00885554010718 | K972599 | 000 |
| 00885554010701 | K972599 | 000 |
| 03596010510778 | K972599 | 000 |
| 03596010510761 | K972599 | 000 |
| 03596010510754 | K972599 | 000 |
| 03596010510747 | K972599 | 000 |
| 03596010510730 | K972599 | 000 |
| 03596010510723 | K972599 | 000 |
| 03596010510716 | K972599 | 000 |
| 03596010510709 | K972599 | 000 |
| 03596010374943 | K972599 | 000 |