FDA UDI
In Commercial Distribution
🇺🇸 United States
3P Hip System
DI: 00840194472845
·
Model: 00-3001-2925
·
ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3P Hip System
- Primary DI
- 00840194472845
- Version / Model
- 00-3001-2925
- Catalog Number
- 00-3001-2925
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-19
- Public Version
- 1
- Public Version Date
- 2025-06-27
- Public Version Status
- New
- Public Device Record Key
- b08c9548-8a92-4616-bccf-09bc4f429658
Device Description
90° Child Offset Plate, 5-Hole, 12mm Offset
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 Conditional
- 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 |
|---|---|---|---|---|
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66945 | Femoral neck fixation plate/sleeve | An implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The sleeve is intended to be introduced into the bone to hold a sliding screw (commonly known as a lag or dynamic screw) and/or a deployable-hook pin [not included] that is implanted into the femoral head/neck to compress the fracture. It is available in various sleeve angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., cortical bone screws), may be included with the plate/sleeve. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194472845 | GS1 |
Customer Contacts
- Phone
- +1(574)268-6379
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243963 | 000 |