Identity
- Trade Name
- Humeral Plating System FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Model / Reference
- Driver, Universal, T15 FDA UDI
Identifiers
- Catalog Number
- DRVR-UQC-T15 FDA UDI
- Primary DI / UDI-DI
- 00841506111445 FDA UDI
- 510(k) Number
- K200367 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical screwdriver, single-use 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
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: Surgical screwdriver, single-use
Humeral Plating System by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, single-use.
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Cleared under the same submission
K200367 also covers:
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — SKELETAL DYNAMICS L.L.C.
- Humeral Fixation Set — 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 9af6d9f8-e5df-4771-8b40-c6fadb30c7f1 35 fields · synced May 30, 2026