FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICE® Plating System
DI: 00887517021663
·
Model: LP4.5-MRT31
·
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PRECICE® Plating System
- Primary DI
- 00887517021663
- Version / Model
- LP4.5-MRT31
- Catalog Number
- LP4.5-MRT31
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-06
- Public Version
- 4
- Public Version Date
- 2025-05-28
- Public Version Status
- Update
- Public Device Record Key
- 4c2cb60c-d955-4a1b-bdfa-6fd7be4cca9b
Device Description
PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole
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
- Yes
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64673 | Long bone distraction plate, magnetic | An implantable device in the form of a plate, capable of adjusting in length, designed to be attached to a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures; each plate is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of overlapping plates, connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887517021663 | GS1 |
Customer Contacts
- Phone
- 866-456-2871
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192181 | 000 |