Identity
- Trade Name
- OIC Sliding Hip Screw (SHS) System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- SLIDING HIP SCREW PLATE, 145 DEGREE, 3 HOLE, STANDARD BARREL 62MM FDA UDI
- Model / Reference
- SHS-145062 FDA UDI
- Description
- SLIDING HIP SCREW PLATE, 145 DEGREE, 3 HOLE, STANDARD BARREL 62MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998032570 FDA UDI
- 510(k) Number
- K113123 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 62 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
OIC Sliding Hip Screw (SHS) System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Proximal Humeral Locking Plate Ⅱ, Combi-holes — Double Medical Technology Inc. · Class II
- ORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Summa Orthopaedics Wrist System Bone Plate — Jeil Medical Corporation · Class II
- Summa Orthopaedics Foot System Bone Plate — Jeil Medical Corporation · Class II
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K113123 also covers:
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
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
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI 01216e2f-b695-4cae-9f6a-ea6160ba54f2 36 fields · synced May 30, 2026