Pds Plates
by Ethicon Inc.
510(k) K092590
Pds Plates is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K092590 on 17 Feb 2010, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092590 | Date17 Feb 2010 | StatusActive |
Official records
- FDA 510(k) database K092590
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHB
- FDA applicant
- ETHICON, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3620
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K092590
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PDS Plates ZFP5 | ZFP5 / ZFP5 | 10705031132511 | — | On the market |
| PDS Plates ZFP6 | ZFP6 / ZFP6 | 10705031132528 | — | On the market |
| PDS Plates ZFP8 | ZFP8 / ZFP8 | 10705031132535 | — | On the market |
| PDS Plates ZX3 | ZX3 / ZX3 | 10705031087934 | — | No longer on the market |
| PDS Plates ZX4 | ZX4 / ZX4 | 10705031087941 | — | No longer on the market |
| PDS Plates ZX5 | ZX5 / ZX5 | 10705031087958 | — | No longer on the market |
| PDS Plates ZX5U | ZX5U / ZX5U | 20705031087962 | — | No longer on the market |
| PDS Plates ZX5U | ZX5U / ZX5U | 10705031087965 | — | No longer on the market |
| PDS Plates ZX6 | ZX6 / ZX6 | 10705031087972 | — | No longer on the market |
| PDS Plates ZX6U | ZX6U / ZX6U | 10705031087989 | — | No longer on the market |
| PDS Plates ZX6U | ZX6U / ZX6U | 20705031087986 | — | No longer on the market |
| PDS Plates ZX7 | ZX7 / ZX7 | 10705031087996 | — | No longer on the market |
| PDS Plates ZX8 | ZX8 / ZX8 | 10705031088009 | — | No longer on the market |
Similar devices
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- LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS by Walter Lorenz Surgical, Inc.