Identity
- Trade Name
- Cement Restrictor FDA UDI
- Generic Name
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
- Device Name
- Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter. FDA UDI
- Model / Reference
- TPA-18 FDA UDI
- Description
- Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497001401 FDA UDI
- 510(k) Number
- K021765 FDA UDI
- FDA Product Code
- JDK 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 18 Millimeter FDA UDI
Category: Polymer orthopaedic cement restrictor, non-bioabsorbable
Cement Restrictor by Tecres — 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
- Definition — Howmedica Osteonics Corp. · Class II
- Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- EXETER — Howmedica Osteonics Corp. · Class II
- BUCK — Smith & Nephew, Inc. · Class II
- Bone Plug — Howmedica Osteonics Corp. · Class II
- Bone Plug — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K021765 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
- Tecres
Sources (1)
- FDA UDI 5dbcf6f8-9f00-4521-8165-3d7d49cbc369 35 fields · synced May 31, 2026