PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
FDA 510(k) clearance K214109 · decided 2022-10-28
Clearance details
- K-number
- K214109
- Device name
- PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
- Applicant
- Kontour(Xi’An) Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-29
- Decision date
- 2022-10-28
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Xi'An, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.