The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Acetabular Bone Screws (for Mobilelink Acetabular Cup System).
| Device ID | K192559 |
| 510k Number | K192559 |
| Device Name: | Acetabular Bone Screws (for MobileLink Acetabular Cup System) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Karen Sonnenberger |
| Correspondent | Terry Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2019-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575427437 | K192559 | 000 |
| 04026575273768 | K192559 | 000 |
| 04026575273775 | K192559 | 000 |
| 04026575273782 | K192559 | 000 |
| 04026575273799 | K192559 | 000 |
| 04026575273805 | K192559 | 000 |
| 04026575427376 | K192559 | 000 |
| 04026575427390 | K192559 | 000 |
| 04026575427406 | K192559 | 000 |
| 04026575427413 | K192559 | 000 |
| 04026575427420 | K192559 | 000 |
| 04026575273751 | K192559 | 000 |