| Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
|---|
| 510(K) Number |
K121392 |
|---|
| Models |
130/32/36/38-32/36/40-51/52/53/54/55,
170-40-00/03/07/93, 170-50-40, 170-50-00/03/07/93,
412-40-00/03/07/10/93
|
| Device Name |
NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE |
|---|
| Applicant |
| EXACTECH, INC. |
| 2320 n.w. 66th ct. |
|
gainesville,
FL
32653
|
|
| Contact |
lindy knisely |
| Regulation Number | 888.3353
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 05/09/2012 |
|---|
| Decision Date | 01/16/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
