Identity
- Trade Name
- LapiLock FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- LapiLock Instrumentation Kit (No Implants Included) FDA UDI
- Model / Reference
- CD-LL-1000-S FDA UDI
- Description
- LapiLock Instrumentation Kit (No Implants Included) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840124511361 FDA UDI
- 510(k) Number
- K211843 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Category: Orthopaedic surgical procedure kit, non-medicated, single-use
LapiLock by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Cleared under the same submission
K211843 also covers:
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- LapiLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 91426a88-eccb-4031-b9be-fecb7d08d620 34 fields · synced May 30, 2026