OSTIM
Bone Grafting Material, Synthetic
HERAEUS KULZER, INC.
The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Ostim.
Pre-market Notification Details
| Device ID | K030052 |
| 510k Number | K030052 |
| Device Name: | OSTIM |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2004-12-06 |
Trademark Results [OSTIM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTIM 77788853 not registered Dead/Abandoned |
FH Orthopedics 2009-07-24 |
 OSTIM 76357435 2947212 Dead/Cancelled |
WARSAW ORTHOPEDIC, INC. 2002-01-14 |
 OSTIM 74234533 1844962 Dead/Cancelled |
Lock, David E. 1991-12-30 |
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