Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
FDA 510(k) clearance K223767 · decided 2023-02-13
Clearance details
- K-number
- K223767
- Device name
- Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
- Applicant
- Stryker Leibinger GmbH & Co KG
- Decision
- Substantially Equivalent
- Date received
- 2022-12-15
- Decision date
- 2023-02-13
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Freiburg Im Breisgau, DE
- Third-party review
- No
- Expedited review
- No
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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 |