FDA UDI
In Commercial Distribution
🇺🇸 United States
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
DI: B278IMTRRHPSM0
·
Model: imtrrhp/Sm
·
ONKOS SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
- Primary DI
- B278IMTRRHPSM0
- Version / Model
- imtrrhp/Sm
- Catalog Number
- IMTRRHP-SM
- Company Name
- ONKOS SURGICAL, INC.
- Labeler DUNS
- 080254074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-19
- Public Version
- 1
- Public Version Date
- 2024-07-29
- Public Version Status
- New
- Public Device Record Key
- a9ce66ff-eeae-43fb-8e4d-3379a1f011b8
Device Description
Rotating Hinge Polyethylene Reamer: Small
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 45114 | Bone-resection orthopaedic reamer, reusable | An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B278IMTRRHPSM0 | HIBCC | ||||
| Previous | 05060296233846 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133152 | 000 |