Identity
- Trade Name
- AC DEVICE FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- Lockdown AO Cortical Tap 3.5mm diameter (Sterile) FDA UDI
- Model / Reference
- LDIN628/S FDA UDI
- Description
- Lockdown AO Cortical Tap 3.5mm diameter (Sterile) FDA UDI
Identifiers
- Catalog Number
- LDIN628/S FDA UDI
- Primary DI / UDI-DI
- 05060433600326 FDA UDI
- 510(k) Number
- K091207 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDI
Category: Bone tap, single-use
Ac Device by Lockdown Medical Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091207 also covers:
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
- AC DEVICE — Lockdown Medical Ltd
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
- Lockdown Medical Ltd
Sources (1)
- FDA UDI f8ce8a2b-de9e-4a57-b18f-e3ac7bd3be67 36 fields · synced Jun 1, 2026