Identity
- Trade Name
- Curved Lenke Probe FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Curved Lenke Probe FDA UDI
- Model / Reference
- 101-0036 FDA UDI
- Description
- Curved Lenke Probe FDA UDI
Identifiers
- Catalog Number
- 101-0036 FDA UDI
- Primary DI / UDI-DI
- 00810097803510 FDA UDI
- 510(k) Number
- K221332 FDA UDI
- FDA Product Code
- HXB FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, reusable 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
Category: Internal spinal fixation procedure kit, reusable
Curved Lenke Probe by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221332 also covers:
- 10.1 Nm TORQUE LIMITER HANDLE — OsteoCentric Technologies,Inc
- 480mm NITINOL GUIDEWIRE — OsteoCentric Technologies,Inc
- 5.5 x 100mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 105mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 110mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 120mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 140mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 150mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 170mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 175mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 180mm CURVED ROD — OsteoCentric Technologies,Inc
- 5.5 x 30mm CANN EXTENSION FASTENER — 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 3a7d346d-1502-4562-b54a-39a7e53adf91 36 fields · synced May 30, 2026