FDA UDI
In Commercial Distribution
🇺🇸 United States
My3D® Personalized Pelvic Reconstruction
DI: B278AP3801604M0
·
Model: AP-38016-04M
·
ONKOS SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- My3D® Personalized Pelvic Reconstruction
- Primary DI
- B278AP3801604M0
- Version / Model
- AP-38016-04M
- Company Name
- ONKOS SURGICAL, INC.
- Labeler DUNS
- 080254074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 1
- Public Version Date
- 2024-04-22
- Public Version Status
- New
- Public Device Record Key
- 4c41766c-7d23-4f9f-8344-c51956f2fcb3
Device Description
APICAL HOLE PLUG, 3/8-16 TPI, 3.5 HEX, FLAT
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56710 | Acetabulum prosthesis hole plug | A sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B278AP3801604M0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212815 | 000 |