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 non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System. FDA UDI
- Model / Reference
- PSS3530CS FDA UDI
- Description
- The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System. FDA UDI
Identifiers
- Catalog Number
- PSS3530CS FDA UDI
- Primary DI / UDI-DI
- 10381780121039 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 b35c79e4-579f-4ec1-9a1e-5ace83d7c542 38 fields · synced Jun 8, 2026