Stryker Resorbable Fixation System
FDA 510(k) clearance K231208 · decided 2023-08-14
Clearance details
- K-number
- K231208
- Device name
- Stryker Resorbable Fixation System
- Applicant
- Stryker Leibinger GmbH & Co KG
- Decision
- Substantially Equivalent
- Date received
- 2023-04-27
- Decision date
- 2023-08-14
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- HBW
- Device class
- 2
- Regulation number
- 882.5360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Freiburg, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Leibinger GmbH & Co KG
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 |
|---|---|---|
| Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472) | Inion OY | 2025-07-11 |
| Stryker Universal Neuro III System AXS Screw (K171152) | Stryker | 2017-05-19 |
| Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387) | Stryker | 2015-06-24 |
| DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (K141385) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835) | Porex Surgical, Inc. | 2010-12-03 |
| MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353) | Biomedical Ent., Inc. | 2001-03-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S018) | Stryker Leibinger GmbH & Co KG | 2023-08-25 |
| TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st (P980052/S012) | Stryker Leibinger, GmbH & Co KG | 2023-08-22 |