Construct® Ankle Fusion Plate System
- Primary DI
- M269PSS6565CT1
- Brand
- Construct® Ankle Fusion Plate System
- Company
- Ascension Orthopedics, Inc.
- Model
- PSS6565CT
- Catalog number
- PSS6565CT
- Device description
- Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
- Published
- 2017-10-09
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| HWC | Screw, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K100176 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780118213 | Primary | GS1 | 0 | |
| M269PSS6565CT1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780118213 | 10381780118213 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 10381780240228 | Cadence™ | 10203024 | 10203024 | 2016-08-24 |
| 10381780240235 | Cadence™ | 10203025 | 2016-08-24 | |
| 10381780240242 | Cadence™ | 10203026 | 2016-08-24 | |
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| 10381780246398 | Integra® | OSG20010PV | OSG-200-10PV | 2017-08-30 |
| 10381780246404 | Integra® | OSG20020P | OSG-200-20P | 2017-08-30 |
| 10381780246411 | Integra® | OSG20020PV | OSG-200-20PV | 2017-08-30 |
| 10381780246428 | Integra® | OSG20030P | OSG-200-30P | 2017-08-30 |
| 10381780246435 | Integra® | OSG20030PV | OSG-200-30PV | 2017-09-05 |
| 10381780246442 | Integra® | OSG20040P | OSG-200-40P | 2017-09-05 |
| 10381780246459 | Integra® | OSG20040PV | OSG-200-40PV | 2017-08-30 |
| 10381780246466 | Integra® | OSG35001 | OSG-350-01 | 2017-08-30 |
| 10381780246473 | Integra® | OSG44200 | OSG-442-00 | 2017-09-05 |
| 10381780246480 | First Choice® DRUJ System | OSG60000 | OSG-600-00 | 2017-09-05 |
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