ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
FDA 510(k) clearance K053293 · decided 2006-02-16
Clearance details
- K-number
- K053293
- Device name
- ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-25
- Decision date
- 2006-02-16
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho Development Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho De recall (Z-2602-2011) | Ortho Development Corporation | 2011-06-20 |
| Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho De recall (Z-2603-2011) | Ortho Development Corporation | 2011-06-20 |