PediLoc Tibia
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ORTHOPEDIATRICS® LOCKING PROXIMAL FEMUR PLATE SYSTEM DISTAL FEMORAL OSTEOTOMY SYSTEM;ORTHOPEDIATRICS® LOCKING CANNULATED BLADE PLATE SYSTEM EUDAMEDPediLoc Tibia FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- ORTHOPEDIATRICS® LOCKING PROXIMAL FEMUR PLATE SYSTEM DISTAL FEMORAL OSTEOTOMY SYSTEM;ORTHOPEDIATRICS® LOCKING CANNULATED BLADE PLATE SYSTEM EUDAMED3.5MM TRANS-PHYSEAL LOCKING SCREW, 66MM LONG, 15MM UNTHREADED TIP FDA UDI
- Model / Reference
- 00-0903-3966 EUDAMEDFDA UDI00-0903-3830 EUDAMED
- Description
- 3.5MM TRANS-PHYSEAL LOCKING SCREW, 66MM LONG, 15MM UNTHREADED TIP FDA UDI
Identifiers
- Catalog Number
- 00-0903-3966 FDA UDI
- Primary DI / UDI-DI
- 00841132129753 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321SSTPUTLU EUDAMED
- 510(k) Number
- K111086 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
PediLoc Tibia by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K111086 also covers:
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (2)
- FDA UDI beb3e70e-f961-4d49-8967-60d5e2ec8c61 36 fields · synced Oct 8, 2026
- EUDAMED 6314ecca-caf5-445c-b195-3e48bf943e25 61 fields · synced Oct 7, 2026