FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIATHLON
DI: 07613327639544
·
Model: 5560-S-016-1
·
Howmedica Osteonics Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TRIATHLON
- Primary DI
- 07613327639544
- Version / Model
- 5560-S-016-1
- Catalog Number
- 5560-S-016-1
- Company Name
- Howmedica Osteonics Corp.
- Labeler DUNS
- 058311945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 1
- Public Version Date
- 2025-09-02
- Public Version Status
- New
- Public Device Record Key
- f8e5eb65-bb56-4abf-9bf0-03374e7ff77c
Device Description
End Cap
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64151 | Knee tibia prosthesis plug | A small, implantable threaded or non-threaded plug intended to fill the hole in the tibial baseplate of a modular knee tibia prosthesis when the knee tibial stem prosthesis is not used. It is made of metallic and/or synthetic polymer materials, and is screwed or pushed into place. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327639544 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251665 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20.0 | Millimeter |