Identity
- Trade Name
- CHENA-C PEEK Spacer System FDA UDI
- Generic Name
- Vertebral body prosthesis, non-sterile FDA UDI
- Device Name
- CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 6mm FDA UDI
- Model / Reference
- CCS1-5-13511-06 FDA UDI
- Description
- CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 6mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B644CCS1513511060 FDA UDI
- 510(k) Number
- K181140 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Vertebral body prosthesis, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vertebral body prosthesis, non-sterile
CHENA-C PEEK Spacer System by Kahtnu Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181140 also covers:
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
- CHENA-C PEEK Spacer System — Kahtnu Surgical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kahtnu Surgical, Inc.
Sources (1)
- FDA UDI 416607ee-c160-4e01-8102-2a9ceefc55a0 34 fields · synced Jun 8, 2026