HYDROXYLAPATITE INFINITY(R)
FDA 510(k) clearance K920969 · decided 1993-05-05
Clearance details
- K-number
- K920969
- Device name
- HYDROXYLAPATITE INFINITY(R)
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1992-03-02
- Decision date
- 1993-05-05
- Days to decision
- 429 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dow Corning Wright
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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |