FDA UDI
In Commercial Distribution
🇺🇸 United States
APEX 3D Total Ankle Replacement System
DI: 00889795153050
·
Model: P99-160-2411
·
Paragon 28, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- APEX 3D Total Ankle Replacement System
- Primary DI
- 00889795153050
- Version / Model
- P99-160-2411
- Catalog Number
- P99-160-2411
- Company Name
- Paragon 28, Inc.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 4
- Public Version Date
- 2025-09-23
- Public Version Status
- Update
- Public Device Record Key
- e9aa1096-9673-49e2-94fa-1c84490e6032
Device Description
Steinmann Pin, 316LVM, Smooth, Ø2.4x110mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HXI | PASSER, WIRE, ORTHOPEDIC | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32854 | Orthopaedic bone pin, non-bioabsorbable | A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889795153050 | GS1 | ||||
| Unit of Use | 70889795153059 | GS1 |