FREEMAN ACETABULAR CUP
FDA 510(k) clearance K852699 · decided 1985-09-05
Clearance details
- K-number
- K852699
- Device name
- FREEMAN ACETABULAR CUP
- Applicant
- Advanced Biosearch Assn.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-26
- Decision date
- 1985-09-05
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Danville, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| PROFEMUR Z REVISION HIP STEM (K122778) | Wrightmedicaltechnologyinc | 2012-10-11 |
| DYNASTY BIOFOAM SHELL (K121544) | Wrightmedicaltechnologyinc | 2012-07-30 |
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| CONSERVE THIN SHELL (K113322) | Wrightmedicaltechnologyinc | 2012-02-03 |
| PRESERVE HIP STEM (K112080) | Wrightmedicaltechnologyinc | 2011-12-28 |
| PROFEMUR GLADIATOR HA HIP STEM (K112150) | Wrightmedicaltechnologyinc | 2011-11-23 |
| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
| GLADIATOR HIP STEM (K111910) | Wrightmedicaltechnologyinc | 2011-10-14 |
| CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836) | Zimmer GmbH | 2011-10-07 |
| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
Recalls involving this device
No recalls on record reference this clearance.