OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
FDA 510(k) clearance K944836 · decided 1995-04-10
Clearance details
- K-number
- K944836
- Device name
- OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-09-30
- Decision date
- 1995-04-10
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteonics Corp.
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 |
|---|---|---|
| Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog recall (Z-0467-03) | Stryker Howmedica Osteonics | 2003-01-28 |