The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Pigalileo Screw Targeting System, Version 1.1.
| Device ID | K092497 |
| 510k Number | K092497 |
| Device Name: | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010648167 | K092497 | 000 |
| 03596010648143 | K092497 | 000 |