Premarket Reviews |
Manufacturer | Decision |
CEREMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CEREMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEMOSTASIS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARINE POLYMER TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOCON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K091121 ORTHOSTAT
|
2. K102762 ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
|
3. K111575 HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
|
4. K121953 HEMASORB APPLY
|
5. K122156 ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
|
6. K123243 HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE P ...
|
7. K140117 AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
|
8. K141502 HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
|
9. K143069 HEMASORBPLUS press Resorable Hemostatic Bone Putty
|
10. K152005 MONTAGE Settable, Resorbable Hemostatic Bone Putty
|
11. K153317 HEMASORBPLUS Resorbable Hemostatic Bone Putty
|
12. K191140 MONTAGE-QS Settable, Resorbable Hemostatic Bone
|
13. K193052 HBP6 Settable, Resorbable Hemostatic Bone Paste
|
14. K202363 HBP7 Settable Hemostatic Bone Putty
|
15. K213418 MONTAGE Settable, Resorbable Hemostatic Bone Putty
|
16. K220315 MONTAGE-XT Settable, Resorbable Hemostatic Bone Pu ...
|
17. K231386 Montage Flowable XRO Settable, Resorbable Hemostat ...
|
18. K232998 Montage- XT Settable, Resorbable Hemostatic Bone P ...
|
ORTHOCON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
1. K091121 ORTHOSTAT
|
2. K102762 ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
|
3. K111575 HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
|
4. K121953 HEMASORB APPLY
|
5. K122156 ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
|
6. K123243 HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE P ...
|
7. K140117 AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
|
8. K141502 HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
|
9. K143069 HEMASORBPLUS press Resorable Hemostatic Bone Putty
|
10. K152005 MONTAGE Settable, Resorbable Hemostatic Bone Putty
|
11. K153317 HEMASORBPLUS Resorbable Hemostatic Bone Putty
|
12. K191140 MONTAGE-QS Settable, Resorbable Hemostatic Bone
|
13. K193052 HBP6 Settable, Resorbable Hemostatic Bone Paste
|
14. K202363 HBP7 Settable Hemostatic Bone Putty
|
15. K213418 MONTAGE Settable, Resorbable Hemostatic Bone Putty
|
16. K220315 MONTAGE-XT Settable, Resorbable Hemostatic Bone Pu ...
|
17. K231386 Montage Flowable XRO Settable, Resorbable Hemostat ...
|
18. K232998 Montage- XT Settable, Resorbable Hemostatic Bone P ...
|
ORTHOCON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESORBABLE ORTHOPEDIC PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL KINETICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES USA PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|