The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Sureshot Distal Targeting System V2.0.
| Device ID | K100107 |
| 510k Number | K100107 |
| Device Name: | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes SMITH & NEPHEW, INC. 1450 BROOKS RD. 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 | 2010-01-14 |
| Decision Date | 2010-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556715147 | K100107 | 000 |
| 03596010648150 | K100107 | 000 |
| 03596010648204 | K100107 | 000 |
| 03596010648211 | K100107 | 000 |
| 03596010648228 | K100107 | 000 |
| 03596010648235 | K100107 | 000 |
| 03596010648266 | K100107 | 000 |
| 03596010648297 | K100107 | 000 |
| 03596010648242 | K100107 | 000 |
| 03596010648259 | K100107 | 000 |
| 00885556120095 | K100107 | 000 |
| 00885556201749 | K100107 | 000 |
| 03596010648136 | K100107 | 000 |