The Micro Screw System, Micro Screw System Basic
FDA 510(k) clearance K201210 · decided 2021-10-08
Clearance details
- K-number
- K201210
- Device name
- The Micro Screw System, Micro Screw System Basic
- Applicant
- Hager& Meisinger GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-05-05
- Decision date
- 2021-10-08
- Days to decision
- 521 days
- Clearance type
- Traditional
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Neuss, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hager& Meisinger GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (K250123) | Hager& Meisinger GmbH | 2025-09-29 |
| Bone Screw (K251569) | Osstem Implant Co., Ltd. | 2025-08-13 |
| USTOMED Bone Fixation/Bone Augmentation Systems - PIN (K243190) | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025-06-27 |
| GBR System (K233419) | Proimtech Saglik Urunleri Anonim Sirketi | 2025-01-03 |
| MP Pin flat without thread (36BMP000020/MP20) (K240321) | Hager& Meisinger GmbH | 2024-10-17 |
| KLS Martin Drill-Free MMF Screw (K233721) | KLS-Martin L.P. | 2024-09-17 |
| Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599) | Stryker Leibinger GmbH & Co KG | 2023-08-24 |
| SAVE GBR (K222367) | Dentis Co., Ltd. | 2023-03-23 |
| Membrane Screws and Membrane Tacks (K201561) | Neoss Limited | 2020-10-05 |
| Bone Screw, Bone Tack (K182881) | Osstem Implant Co., Ltd. | 2019-08-09 |
| OssBuilder System (K181854) | Osstem Implant Co., Ltd. | 2019-05-07 |
| Intra-Lock Bone Fixation System (K171831) | Intra-Lock International, Inc. | 2017-10-26 |
Recalls involving this device
No recalls on record reference this clearance.