The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for External Fixation Clamp 5.0 Mm Pin X9.5mm Rod, Model 1151-100, External Fixaton Clamp, 9.5mm Rod.
| Device ID | K080408 |
| 510k Number | K080408 |
| Device Name: | EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501 |
| Product Code | KTT |
| Subsequent Product Code | JDW |
| Subsequent Product Code | JEC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2008-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665016802 | K080408 | 000 |
| 00848665005493 | K080408 | 000 |
| 00848665005455 | K080408 | 000 |
| 00848665005448 | K080408 | 000 |
| 00848665005431 | K080408 | 000 |
| 00848665005424 | K080408 | 000 |
| 00848665005417 | K080408 | 000 |
| 00848665005400 | K080408 | 000 |
| 00848665005394 | K080408 | 000 |
| 00848665005387 | K080408 | 000 |
| 00848665005370 | K080408 | 000 |
| 00848665034318 | K080408 | 000 |
| 00848665005509 | K080408 | 000 |
| 00848665005516 | K080408 | 000 |
| 00848665016796 | K080408 | 000 |
| 00848665016789 | K080408 | 000 |
| 00848665016772 | K080408 | 000 |
| 00848665016765 | K080408 | 000 |
| 00848665016758 | K080408 | 000 |
| 00848665016741 | K080408 | 000 |
| 00848665016734 | K080408 | 000 |
| 00848665016727 | K080408 | 000 |
| 00848665016710 | K080408 | 000 |
| 00848665013573 | K080408 | 000 |
| 00848665005523 | K080408 | 000 |
| 00848665024135 | K080408 | 000 |