Device Classification Name |
Bone Cement, Antibiotic
|
510(k) Number |
K190216 |
Device Name |
SpaceFlex Knee |
Applicant |
G21 S.R.L |
Via Sandro Petrini, 8 |
San Possidonio,
IT
41039
|
|
Applicant Contact |
Filippo Foroni |
Correspondent |
RQMIS, Inc. |
110 Haverhill Road, Suite 526 |
Amesbury,
MA
01913
|
|
Correspondent Contact |
Manjusha Bharadwaj |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/04/2019 |
Decision Date | 06/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|