OSTEOPAL
Bone Cement
HERAEUS KULZER GMBH & CO. KG
The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Osteopal.
Pre-market Notification Details
| Device ID | K030903 |
| 510k Number | K030903 |
| Device Name: | OSTEOPAL |
| Classification | Bone Cement |
| Applicant | HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau, DE D-63450 |
| Contact | K.d. Kuhn |
| Correspondent | K.d. Kuhn HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau, DE D-63450 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-09-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135567 | K030903 | 000 |
| B5780011181400114 | K030903 | 000 |
Trademark Results [OSTEOPAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOPAL 87410764 not registered Live/Pending |
Heraeus Medical GmbH 2017-04-13 |
 OSTEOPAL 74470554 2031356 Live/Registered |
HERAEUS MEDICAL GMBH 1993-12-17 |
 OSTEOPAL 74442278 not registered Dead/Abandoned |
MALLINCKRODT, INC. 1993-09-29 |
 OSTEOPAL 73633752 1444843 Dead/Cancelled |
E. MERCK 1986-12-04 |
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