510(k) K080979 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 31, 2008 |
| Received | Apr 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199. Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.