FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Precice®
DI: 00887517024985
·
Model: STP6-850-A
·
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Precice®
- Primary DI
- 00887517024985
- Version / Model
- STP6-850-A
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-15
- Public Version
- 5
- Public Version Date
- 2025-05-28
- Public Version Status
- Update
- Public Device Record Key
- 5662341f-5234-4fc5-98f9-cd55b3cc92e7
- Distribution End Date
- 2024-02-07
Device Description
6.0mmx85mm Locking Screw, PT
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
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65265 | Arthrodesis intramedullary nail, magnetic distraction | A rigid magnetic rod, capable of adjusting in length (lengthen), dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone (e.g., tibia) which extends beyond the joint to an adjacent bone(s) [e.g., calcaneus], in traumatic repair or reconstructive procedures. It consists of telescoping rods connected to the bone with screws, which have one or more integrated magnets that are designed to move in response to a noninvasive magnetic control device (not included) to adjust length providing distraction. It is made of metal or other material (e.g., carbon fibre). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887517024985 | GS1 |
Customer Contacts
- Phone
- 866-456-2871
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200430 | 000 |