The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Acufex Director Application Anatomic Guide System.
| Device ID | K111843 |
| 510k Number | K111843 |
| Device Name: | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554024135 | K111843 | 000 |