FDA device listing
ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE,ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE,ATTUNE REVISION SOLID RP…
FDA device listing 1111573509 · DePuy Synthes, Inc.
Key facts
| Proprietary names | ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE,ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE,ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE,ATTUNE REVISION TIBIAL BROACH CADDY,instrument tray, instrument case,PINNACLE Dual Mobility,Viper Prime |
|---|---|
| Owner/operator | DePuy Synthes, Inc. |
| Owner/operator number | 1818910 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | DEPUY INTL., LTD., DEPUY (IRELAND), Depuy Ireland UC, DEPUY ORTHOPAEDICS, DEPUY ORTHOPAEDICS, INC., JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. |
| Establishment registrations | 1219655, 1818910, 8010379, 9616671, 3004464325, 3006356043, 3015516266 |
| FEI numbers | 1219655, 1818910, 1000199976, 3002854251, 3004464325, 3006356043, 3015516266 |
| Establishment operations | Manufacturer, Specification Developer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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