Identity
- Trade Name
- PediNail FDA UDI
- Generic Name
- Orthopaedic bone bolt FDA UDI
- Device Name
- HEADLESS LOCKING BOLT, 32MM FDA UDI
- Model / Reference
- 00-1500-6532 FDA UDI
- Description
- HEADLESS LOCKING BOLT, 32MM FDA UDI
Identifiers
- Catalog Number
- 00-1500-6532 FDA UDI
- Primary DI / UDI-DI
- 00841132129449 FDA UDI
- 510(k) Number
- K083726 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone bolt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Orthopaedic bone bolt
PediNail by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083726 also covers:
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 1739ec93-7d22-4f35-9704-1448620e9aa7 36 fields · synced May 31, 2026