TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
FDA 510(k) clearance K033230 · decided 2003-12-12
Clearance details
- K-number
- K033230
- Device name
- TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
- Applicant
- Parallax Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-06
- Decision date
- 2003-12-12
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- MYU
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Scotts Valley, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Parallax Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BONE CEMENT RADIO-OPACIFIER (K032388) | Cardinalhealth | 2003-10-31 |
| VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (K024359) | Vista Scientific, LLC | 2003-08-08 |
| TRACERS BONE CEMENT OPACIFIER (K023445) | Parallax Medical, Inc. | 2003-03-11 |
| BIOTRACE, MODEL 1730 (K002063) | Bryan Corp. | 2000-08-10 |
| PARALLAX TRACER RADIOPAQUE PARTICLES (K991893) | Parallax Medical, Inc. | 1999-08-13 |
Recalls involving this device
No recalls on record reference this clearance.