The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Spar-k Instruments (for Use With Gemini Sl Total Knee System).
| Device ID | K191755 |
| 510k Number | K191755 |
| Device Name: | SPAR-K Instruments (for Use With Gemini SL Total Knee System) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Terry Sheridan Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575229765 | K191755 | 000 |
| 04026575216918 | K191755 | 000 |
| 04026575216901 | K191755 | 000 |
| 04026575216895 | K191755 | 000 |
| 04026575216888 | K191755 | 000 |
| 04026575216871 | K191755 | 000 |
| 04026575216864 | K191755 | 000 |
| 04026575216123 | K191755 | 000 |
| 04026575216116 | K191755 | 000 |
| 04026575216109 | K191755 | 000 |
| 04026575216093 | K191755 | 000 |
| 04026575215683 | K191755 | 000 |
| 04026575216925 | K191755 | 000 |
| 04026575216932 | K191755 | 000 |
| 04026575229505 | K191755 | 000 |
| 04026575229055 | K191755 | 000 |
| 04026575182503 | K191755 | 000 |
| 04026575242771 | K191755 | 000 |
| 04026575242757 | K191755 | 000 |
| 04026575221745 | K191755 | 000 |
| 04026575221370 | K191755 | 000 |
| 04026575221301 | K191755 | 000 |
| 04026575221035 | K191755 | 000 |
| 04026575221028 | K191755 | 000 |
| 04026575220946 | K191755 | 000 |
| 04026575184309 | K191755 | 000 |