Identity
- Trade Name
- Escalade Acetabular System FDA UDI
- Generic Name
- Acetabulum prosthesis hole plug FDA UDI
- Device Name
- Apical Screw Plug FDA UDI
- Model / Reference
- 170-0301 FDA UDI
- Description
- Apical Screw Plug FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409017102 FDA UDI
- 510(k) Number
- K103384 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDI
- GMDN Term
- Acetabulum prosthesis hole plug FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
Category: Acetabulum prosthesis hole plug
Escalade Acetabular System by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis hole plug.
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- ORTHOLOC™ 2 Jones Fracture System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Converge® — Zimmer, Inc. · Class II
- R3 — Smith & Nephew, Inc. · Class II
- Logical Hole Cover — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K103384 also covers:
- CoCr Femoral Head — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP.
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 |
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Manufacturer
- Manufacturer
- Ortho Development Corp.
Sources (1)
- FDA UDI c4a80342-2190-43a1-a941-4fe047cff1b9 35 fields · synced Jun 8, 2026