Identity
- Trade Name
- Lateral Dilator FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Model / Reference
- SR21-6000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850040139884 FDA UDI
- 510(k) Number
- K230446 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, bioabsorbable
Lateral Dilator by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, bioabsorbable.
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- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 1.5 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
Cleared under the same submission
K230446 also covers:
- Guidewire - 12" — SURGENTEC LLC
- Guidewire - 15.5" — SURGENTEC LLC
- Lateral Drill Guide — SURGENTEC LLC
- Lateral Graft Tamp — SURGENTEC LLC
- Lateral Impact Cap — SURGENTEC LLC
- Lateral Removal Tool — SURGENTEC LLC
- Lateral SI Screw Drill Bit - 8mm — SURGENTEC LLC
- Lateral SI Screw Inserter Torque Driver — SURGENTEC LLC
- SI-Lateral Ratcheting T-Handle — SURGENTEC LLC
- TILINK-L GUIDE PIN LOCATOR — SURGENTEC LLC
- TILINK-L GUIDE PIN LOCATOR 16mm — SURGENTEC LLC
- TiLink-L Bone Graft Funnel — SURGENTEC LLC
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 |
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Manufacturer
- Manufacturer
- Surgentec Llc
Sources (1)
- FDA UDI ab2f3a04-6d06-49ff-a0fd-66eee54faed6 33 fields · synced Jun 6, 2026