Product code JDY
- Device name
- Evacuator, Vapor, Cement Monomer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4220
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Arbor Technologies, Inc. | 1991-01-04 |
| K902056 | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Hollister, Inc. | 1990-10-30 |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | 1986-07-23 |
| K810542 | CEMENT FUME EVACUATOR TANK & FILTER | Walgen Medical Innoventions | 1981-03-13 |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | Stackhouse Assoc. | 1979-05-23 |
| K780202 | MONOMER EVACUATION SYSTEM | Medishield, Inc. | 1978-02-21 |
| K770690 | MASK, VAPOR, MONOMER | Howmedica Corp. | 1977-07-21 |
| K760906 | MONOMER VAPOR CONTAINMENT SYSTEM | Howmedica Corp. | 1976-11-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842962102091 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-05-27 |
| 00842962104309 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-05-27 |
| 15060238200148 | SmartMix Vacuum Footpump and Airhose | SUMMIT MEDICAL LIMITED | 2023-02-09 |
| 15060238200278 | Summit Medical High Vacuum Footpump + Air Hose | SUMMIT MEDICAL LIMITED | 2023-02-09 |
| 15060238200452 | SmartMix CemVac Dual Vacuum Footpump & Airhose | SUMMIT MEDICAL LIMITED | 2023-02-09 |
| 04260056881022 | EASYMIX® compressed air hose | OSARTIS GmbH | 2022-12-01 |
| 04260056881039 | EASYMIX® compressed air hose | OSARTIS GmbH | 2022-12-01 |
| 04260056881633 | EASYMIX® vacuum pump I | OSARTIS GmbH | 2022-12-01 |
| 04260056881930 | EASYMIX® vacuum pump II | OSARTIS GmbH | 2022-12-01 |
| 00889024374904 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2021-03-03 |
| 04260102131231 | PALAMIX® | Heraeus Medical GmbH | 2019-05-15 |
| 00889024374867 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2019-03-08 |
| 00889024374874 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2019-03-08 |
| 00889024374881 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2019-03-08 |
| 00889024374898 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2019-03-08 |
| 00889024376670 | Miller™ | Zimmer, Inc. | 2016-10-10 |
| 00889024382107 | Miller™ | Zimmer, Inc. | 2016-10-10 |