510(k) K181348
- Device
- Cartiva SCI Disposable Instrumentation Set
- Applicant
- Cartiva, Inc.
- 510(k) number
- K181348
- Product code
- QBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-20
- Date received
- 2018-05-21
- Regulation
- 888.4505
- Classification name
- Instruments Designed For Press-fit Osteochondral Implants
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tanya Eberle
- Address
- 6120 Windward Pkwy. Suite 220 Alpharetta GA US 30005 30005
FDA Registration Numbers#
- 2249062
- 3031343865
- 8043971
- 3002808227
- 1834331
- 3010388970
- 3013881076
- 3006742481
- 9616671
- 3008812241
- 3015516266
- 1818910
- 1000307092
- 8010379
- 3009582259
Source Documents#
Other 510(k) Records For Product Code QBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192156 | Cartiva SCI instrumentation set | Cartiva, Inc. | 2019-09-04 |
Legacy Summary#
summary
FDA Review#
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