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OrthoPediatrics PediFoot Deformity Correction System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 00-1007-3516Model 00-1007-2705
Identity
- Trade Name
- ORTHOPEDIATRICS®PEDIFOOT DEFORMITY CORRECTION SYSTEM EUDAMEDOrthoPediatrics PediFoot Deformity Correction System FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- ORTHOPEDIATRICS®PEDIFOOT DEFORMITY CORRECTION SYSTEM EUDAMED3.5mm Variable Angle Locking Screw, 16mm FDA UDI
- Model / Reference
- 00-1007-3516 EUDAMEDFDA UDI00-1007-2705 EUDAMED
- Description
- 3.5mm Variable Angle Locking Screw, 16mm FDA UDI
Identifiers
- Catalog Number
- 00-1007-3516 FDA UDI
- Primary DI / UDI-DI
- 00841132158524 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321SSVALH7 EUDAMED
- 510(k) Number
- K190992 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
OrthoPediatrics PediFoot Deformity Correction System by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- AYSAM — Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi · Class IIb
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
Cleared under the same submission
K190992 also covers:
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 dc7a5bc6-7309-4483-afdd-496d18f5a9fc 36 fields · synced Oct 7, 2026
- EUDAMED 298bcccb-882d-4ea5-b2d6-e6e3f2a7dadd 61 fields · synced Oct 7, 2026