OTO-CEM
FDA 510(k) clearance K011338 · decided 2001-09-13
Clearance details
- K-number
- K011338
- Device name
- OTO-CEM
- Applicant
- Ototech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-02
- Decision date
- 2001-09-13
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- NEA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROCEM (K140644) | Ototronix, LLC | 2014-06-19 |
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |
| STRYKER INJECTABLE CEMENT (K060750) | Stryker Cmf | 2006-04-19 |
| OTOMIMIX (K042516) | Walter Lorenz Surgical, Inc. | 2004-11-08 |
| SERENOCEM, MODEL BC 010 (K003567) | Corinthian Medical , Ltd. | 2001-02-12 |
Recalls involving this device
No recalls on record reference this clearance.