Identity
- Trade Name
- IJS-E FDA UDI
- Generic Name
- Elbow stabilization implant FDA UDI
- Device Name
- IJS-E Base Plate Assembly, Proximal Ulna Plate FDA UDI
- Model / Reference
- IJS FDA UDI
- Description
- IJS-E Base Plate Assembly, Proximal Ulna Plate FDA UDI
Identifiers
- Catalog Number
- IJS-PUP-BPA FDA UDI
- Primary DI / UDI-DI
- 00841506109107 FDA UDI
- FDA Product Code
- OZI FDA UDILXT FDA UDI
- GMDN Term
- Elbow stabilization implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Moist Heat or Steam Sterilization FDA UDI
Category: Elbow stabilization implant
Ijs-E by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elbow stabilization implant.
- IJS-E — SKELETAL DYNAMICS L.L.C. · Class II
- IJS — SKELETAL DYNAMICS L.L.C. · Class II
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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI d1ac257b-87d0-4392-9976-00a5bb76e80e 35 fields · synced May 31, 2026