510(k) K183141 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LINK MP Monoblock Hip Prosthesis
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Nov 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183141
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.
Item Number: 136-114/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.
Item Number: 136-115/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-116/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-117/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-118/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-119/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-120/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-121/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-22/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-23/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-24/00 Open, Classified |
LZO | None listed |
| Aug 4, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-25/00 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.