Cartiva SCI instrumentation set
FDA 510(k) clearance K192156 · decided 2019-09-04
Clearance details
- K-number
- K192156
- Device name
- Cartiva SCI instrumentation set
- Applicant
- Cartiva, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-09
- Decision date
- 2019-09-04
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- QBO
- Device class
- 2
- Regulation number
- 888.4505
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Alpharetta, GA, US
- 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 |
|---|---|---|
| Cartiva SCI Disposable Instrumentation Set (K181348) | Cartiva, Inc. | 2018-06-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cartiva Synthetic Cartilage Implant (SCI) (P150017/S015) | Cartiva, Inc. | 2021-12-10 |
| Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S013) | Cartiva, Inc. | 2020-02-09 |
| Cartiva Synthetic Cartilage Implant (P150017/S014) | Cartiva, Inc. | 2019-11-26 |
| Cartiva Synthetic Cartilage Implant (P150017/S011) | Cartiva, Inc. | 2019-07-12 |
| Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S010) | Cartiva, Inc. | 2019-07-11 |
| Cartiva Synthetic Cartilage Implant (P150017/S012) | Cartiva, Inc. | 2019-03-22 |
| Cartiva SCI reusable instrumentation (P150017/S007) | Cartiva, Inc. | 2018-08-28 |
| Cartiva SCI (P150017/S009) | Cartiva, Inc. | 2018-07-02 |