Identity
- Trade Name
- IMPlate FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Model / Reference
- IMPLATE Wrist Arthrodesis Nail System FDA UDI
Identifiers
- Catalog Number
- IMP-WAN-SYS FDA UDI
- Primary DI / UDI-DI
- 00841506102320 FDA UDI
- 510(k) Number
- K092720 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
No
FDA UDI
Implantable
No
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: General internal orthopaedic fixation system implantation kit
IMPlate by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
K092720 also covers:
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
- IMPlate — SKELETAL DYNAMICS L.L.C.
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 67b8a932-453f-4e42-ba5a-f0a91f94dc7a 35 fields · synced May 30, 2026