The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Swift-lock Anchor, Model 1192.
| Device ID | K092371 |
| 510k Number | K092371 |
| Device Name: | SWIFT-LOCK ANCHOR, MODEL 1192 |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Penny Houston |
| Correspondent | Penny Houston ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734400678 | K092371 | 000 |