FDA device listing
COMPRESS ANTI-ROTATION SPINDLES
FDA device listing 1611440983 · ZimmerBiomet Americas DFE
Key facts
| Proprietary names | COMPRESS ANTI-ROTATION SPINDLES |
|---|---|
| Owner/operator | ZimmerBiomet Americas DFE |
| Owner/operator number | 10056779 |
| Premarket submissions | K101475 |
| Product codes | JDI, JDL, KRO, KWA, KWY, KWZ, LPH, LZO, MEH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, JDL - Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), KRO - Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, KWA - Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 888.3310, 888.3320, 888.3330, 888.3350, 888.3353, 888.3358, 888.3390, 888.3510 |
| Review panels | Orthopedic |
| Registered establishments | BIOMET CHILE S.A. |
| Establishment registrations | 3014302784 |
| FEI numbers | 3014302784 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database