FDA UDI
In Commercial Distribution
🇺🇸 United States
VSP Orthopedics
DI: 00816847021876
·
Model: Allograft Tibia Template
·
3D SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VSP Orthopedics
- Primary DI
- 00816847021876
- Version / Model
- Allograft Tibia Template
- Company Name
- 3D SYSTEMS, INC.
- Labeler DUNS
- 085049749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-11
- Public Version
- 2
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 28658b87-02b8-43dd-896d-0469ddd96e36
Device Description
A physical template that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60826 | Custom-made orthopaedic/craniofacial surgical guide | A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816847021876 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190044 | 000 |