The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Addplus.
| Device ID | K090841 | 
| 510k Number | K090841 | 
| Device Name: | ADDPLUS | 
| Classification | Spinal Vertebral Body Replacement Device | 
| Applicant | ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 | 
| Contact | Merle Symes | 
| Correspondent | Merle Symes ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 | 
| Product Code | MQP | 
| CFR Regulation Number | 888.3060 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2009-03-27 | 
| Decision Date | 2009-10-05 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 04052536090570 | K090841 | 000 | 
| 04052536002443 | K090841 | 000 | 
| 04052536002436 | K090841 | 000 | 
| 04052536009343 | K090841 | 000 | 
| 04052536007264 | K090841 | 000 | 
| 04052536007233 | K090841 | 000 | 
| 04052536007226 | K090841 | 000 | 
| 04052536007219 | K090841 | 000 | 
| 04052536007202 | K090841 | 000 | 
| 04052536007196 | K090841 | 000 | 
| 04052536007189 | K090841 | 000 | 
| 04052536007165 | K090841 | 000 | 
| 04052536007059 | K090841 | 000 | 
| 04052536007042 | K090841 | 000 | 
| 04052536006779 | K090841 | 000 | 
| 04052536002450 | K090841 | 000 | 
| 04052536002467 | K090841 | 000 | 
| 04052536009381 | K090841 | 000 | 
| 04052536009374 | K090841 | 000 | 
| 04052536009367 | K090841 | 000 | 
| 04052536009350 | K090841 | 000 | 
| 04052536006854 | K090841 | 000 | 
| 04052536006847 | K090841 | 000 | 
| 04052536006830 | K090841 | 000 | 
| 04052536002535 | K090841 | 000 | 
| 04052536002528 | K090841 | 000 | 
| 04052536002511 | K090841 | 000 | 
| 04052536002504 | K090841 | 000 | 
| 04052536002498 | K090841 | 000 | 
| 04052536002481 | K090841 | 000 | 
| 04052536002474 | K090841 | 000 | 
| 04052536009985 | K090841 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ADDPLUS  98515900  not registered Live/Pending | Nanchang Haitang E-Commerce Co., Ltd. 2024-04-23 | 
|  ADDPLUS  98005826  not registered Live/Pending | Zhang, Guowei 2023-05-20 | 
|  ADDPLUS  97859668  not registered Live/Pending | Zhang Guowei 2023-03-27 | 
|  ADDPLUS  97419964  not registered Live/Pending | Zhang Guowei 2022-05-19 | 
|  ADDPLUS  88262049  not registered Live/Pending | Ulrich Medical USA Inc. 2019-01-15 |