Integra® Proximal Humeral Fracture Plate System
Basic Information
- Brand Name
- Integra® Proximal Humeral Fracture Plate System
- Primary DI
- 10381780064626
- Version / Model
- HFPLATEIMP
- Catalog Number
- HFPLATEIMP
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-22
- Public Version
- 5
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- c16642e5-47a9-40f7-9d39-7c9edff05e1c
- Distribution End Date
- 2023-03-31
Device Description
The Integra Proximal Humeral Fracture Plate System will be composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The plates and screws are made of 316L Stainless Steel. The GT plate is designed to cover the greater tuberosity and is available in four-hole, seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system will also feature 3.5mm locking screws, non-locking compression screws and non-locking partial thread screws. In addition 2.7mm locking screws are also available. The system is indicated for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Instruments are provided to assist with the implants.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62467 | Surgical soft-tissue manipulation forceps, alligator, reusable | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M268HFPLATEIMP1 | HIBCC | ||||
| Primary | 10381780064626 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121826 | 000 |