FDA UDI
In Commercial Distribution
🇺🇸 United States
The Locking Pediatric Osteotomy Plate (LolliPOP) System
DI: 07540194013156
·
Model: POP-IB-45
·
Orthopediatrics Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- The Locking Pediatric Osteotomy Plate (LolliPOP) System
- Primary DI
- 07540194013156
- Version / Model
- POP-IB-45
- Catalog Number
- POP-IB-45
- Company Name
- Orthopediatrics Canada ULC
- Labeler DUNS
- 243298854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-14
- Public Version
- 4
- Public Version Date
- 2025-05-13
- Public Version Status
- Update
- Public Device Record Key
- 30359d22-8253-473b-8ab8-a7bdd8fb54cb
Device Description
BLADE, INFANT 45mm
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
- Yes
- 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 |
|---|---|---|---|---|
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66943 | Femoral fixation plate/blade | An implantable, non-customized sheet of firm material that incorporates a blade at one end designed to be attached with screws to the proximal and/or distal femur to treat a fracture; the blade is intended to be introduced into the bone to assist with fixation. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available is various blade angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate/blade. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540194013156 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170704 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep at room temperature