Identity
- Trade Name
- Bone Plug FDA UDI
- Generic Name
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
- Device Name
- Canal -Cemented FDA UDI
- Model / Reference
- 6215-5-001 FDA UDI
- Description
- Canal -Cemented FDA UDI
Identifiers
- Catalog Number
- 6215-5-001 FDA UDI
- Primary DI / UDI-DI
- 07613327036664 FDA UDI
- FDA Product Code
- LZN FDA UDI
- GMDN Term
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Category: Polymer orthopaedic cement restrictor, non-bioabsorbable
Bone Plug by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.
- Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- MectaPlug PE II — Medacta International · Class II
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- BUCK — Smith & Nephew, Inc. · Class II
- Signature Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- INTRAMEDULLARY BONE PLUG — Biomet Orthopedics, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- BIO PLUG — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K220838 also covers:
- Bone Plug — Howmedica Osteonics Corp.
- Bone Plug — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
- Restrictor — Howmedica Osteonics Corp.
K951860 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI bf4b9635-42c3-47fd-97be-38533128bf67 36 fields · synced May 31, 2026