Identity
- Trade Name
- IMPlate FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Model / Reference
- IMPLATE Nail, Metacarpal, Standard, 4.0mm FDA UDI
Identifiers
- Catalog Number
- IMP-MCN-S40 FDA UDI
- Primary DI / UDI-DI
- 00841506102160 FDA UDI
- 510(k) Number
- K092720 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting 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
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
IMPlate by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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 bec15fb2-3d1a-4962-96b7-90d3a12c5636 36 fields · synced May 30, 2026