TROCHANTER MESH
FDA 510(k) clearance K945027 · decided 1995-02-01
Clearance details
- K-number
- K945027
- Device name
- TROCHANTER MESH
- Applicant
- Acu Med, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-10-13
- Decision date
- 1995-02-01
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- EZX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ANOVA CONTAINMENT DEVICE (K063461) | Anova Corporation | 2009-08-13 |
| OPTIMESH (K014200) | Spineology, Inc. | 2003-11-26 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (K032344) | Implex Corp. | 2003-10-02 |
| MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K032282) | Implex Corp. | 2003-08-21 |
| MACROPORE OS RECONSTRUCTION (K024169) | Macropore Biosurgery, Inc. | 2003-07-01 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K023882) | Implex Corp. | 2003-02-19 |
| NUVASIVE MESH (K020853) | Nuvasive, Inc. | 2002-06-13 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
| MOTECH TITANIUM SURGICAL MESH (K900138) | Biedermann Motech GmbH | 1990-03-20 |
| TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369) | Techmedica, Inc. | 1989-11-24 |
| STUART TITANIUM SURGICAL MESH (K890601) | Stuart | 1989-03-16 |
Recalls involving this device
No recalls on record reference this clearance.