The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Stryker Leibinger Skeletal Anchoring System.
| Device ID | K041651 |
| 510k Number | K041651 |
| Device Name: | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-17 |
| Decision Date | 2004-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154732715 | K041651 | 000 |
| 04546540435675 | K041651 | 000 |
| 04546540435668 | K041651 | 000 |
| 04546540435651 | K041651 | 000 |
| 04546540435644 | K041651 | 000 |
| 04546540435637 | K041651 | 000 |
| 04546540435620 | K041651 | 000 |
| 04546540435613 | K041651 | 000 |
| 04546540435606 | K041651 | 000 |
| 04546540435590 | K041651 | 000 |
| 04546540435682 | K041651 | 000 |
| 04546540435699 | K041651 | 000 |
| 07613154732456 | K041651 | 000 |
| 07613154732227 | K041651 | 000 |
| 07613154732173 | K041651 | 000 |
| 07613154731954 | K041651 | 000 |
| 07613154731367 | K041651 | 000 |
| 07613154730575 | K041651 | 000 |
| 07613154370214 | K041651 | 000 |
| 07613154274765 | K041651 | 000 |
| 07613154274758 | K041651 | 000 |
| 04546540435583 | K041651 | 000 |