Identity
- Trade Name
- 8.0MM TAP CANN HUD-MOD FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- 8.0MM TAP CANN HUD-MOD FDA UDI
- Model / Reference
- 202-1104 FDA UDI
- Description
- 8.0MM TAP CANN HUD-MOD FDA UDI
Identifiers
- Catalog Number
- 202-1104 FDA UDI
- Primary DI / UDI-DI
- 00810097802872 FDA UDI
- 510(k) Number
- K230226 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
8.0mm Tap Cann Hud-Mod by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
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Cleared under the same submission
K230226 also covers:
- 10 X 67.5MM SI FUSION FASTENER CANN STERILE — OsteoCentric Technologies,Inc
- 10 X 72.5MM SI FUSION FASTENER CANN STERILE — OsteoCentric Technologies,Inc
- 10 X 77.5MM SI FUSION FASTENER CANN — OsteoCentric Technologies,Inc
- 10 X 77.5MM SI FUSION FASTENER CANN STERILE — OsteoCentric Technologies,Inc
- 10 X 82.5MM SI FUSION FASTENER CANN STERILE — OsteoCentric Technologies,Inc
- 10 x 100mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 105mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 60mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 65mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 75mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 80mm SI Fusion Fastener Cann — OsteoCentric Technologies,Inc
- 10 x 85mm SI Fusion Fastener Cann — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 0370aec6-352f-44e9-8119-5e1039717b04 37 fields · synced Jun 8, 2026