Identity
- Trade Name
- Integra® Proximal Humeral Fracture Plate System FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, alligator, reusable FDA UDI
- Device Name
- The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in three-hole. FDA UDI
- Model / Reference
- HFP0930103RS FDA UDI
- Description
- The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in three-hole. FDA UDI
Identifiers
- Catalog Number
- HFP0930103RS FDA UDI
- Primary DI / UDI-DI
- 10381780120841 FDA UDI
- 510(k) Number
- K121826 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, alligator, reusable 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical soft-tissue manipulation forceps, alligator, reusable
Integra® Proximal Humeral Fracture Plate System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical soft-tissue manipulation forceps, alligator, reusable.
- Integra® — Integra LifeSciences Production Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Symmetry Goodhill — SYMMETRY SURGICAL INC. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Micro laryngeal forceps — Spiggle & Theis Medizintechnik GmbH · Class I
- Symmetry Jako — SYMMETRY SURGICAL INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Cleared under the same submission
K121826 also covers:
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
- Integra® Proximal Humeral Fracture Plate System — Ascension Orthopedics, Inc.
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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI b16ddeb8-01cc-48ed-b502-72f7a419bec4 38 fields · synced May 30, 2026