Stryker MP, Mandible, HMMF and MMF AXS Screws
FDA 510(k) clearance K231599 · decided 2023-08-24
Clearance details
- K-number
- K231599
- Device name
- Stryker MP, Mandible, HMMF and MMF AXS Screws
- Applicant
- Stryker Leibinger GmbH & Co KG
- Decision
- Substantially Equivalent
- Date received
- 2023-06-01
- Decision date
- 2023-08-24
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Freiburg, DE
- Third-party review
- No
- Expedited review
- No
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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 |
| SAVE GBR (K222367) | Dentis Co., Ltd. | 2023-03-23 |
| The Micro Screw System, Micro Screw System Basic (K201210) | Hager& Meisinger GmbH | 2021-10-08 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant (P130014/S022) | Stryker Leibinger GmbH & Co KG | 2026-07-15 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S017) | Stryker Leibinger, GmbH & Co KG | 2026-03-06 |
| Adherus AutoSpray Dural Sealant (P130014/S021) | Stryker Leibinger GmbH & Co KG | 2025-11-06 |
| TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System (P980052/S016) | Stryker Leibinger, GmbH & Co KG | 2025-07-23 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S020) | Stryker Leibinger GmbH & Co KG | 2024-08-29 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S015) | Stryker Leibinger, GmbH & Co KG | 2024-08-08 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S014) | Stryker Leibinger, GmbH & Co KG | 2024-07-30 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S019) | Stryker Leibinger GmbH & Co KG | 2023-10-07 |