Identity
- Trade Name
- LSI Arthroereisis Peg FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- LSI Implant Medium Plus FDA UDI
- Model / Reference
- SG-LD-0502-S FDA UDI
- Description
- LSI Implant Medium Plus FDA UDI
Identifiers
- Catalog Number
- SG-LD-0502-S FDA UDI
- Primary DI / UDI-DI
- 00819034029532 FDA UDI
- 510(k) Number
- K922292 FDA UDI
- FDA Product Code
- MJW FDA UDI
- GMDN Term
- Subtalar implant, non-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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Subtalar implant, non-bioabsorbable
LSI Arthroereisis Peg by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subtalar implant, non-bioabsorbable.
- HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
- Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
- HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
- HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
- bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC. · Class II
Cleared under the same submission
K922292 also covers:
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, 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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI a1f122ed-ea0f-4feb-8549-0a7cd6568146 35 fields · synced Jun 8, 2026