Identity
- Trade Name
- FastFrame™ FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Model / Reference
- 47-5300-010-01 FDA UDI
Identifiers
- Catalog Number
- 47-5300-010-01 FDA UDI
- Primary DI / UDI-DI
- 00889024464100 FDA UDI
- 510(k) Number
- K152484 FDA UDI
- FDA Product Code
- KTT 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical screwdriver, single-use
FastFrame™ by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, single-use.
- MS Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
- HEX DRIVER 3.0 3.5 — BIOPRO, INC. · Class I
- Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- Orthodontic Screw Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
- HammerTech — FUSION ORTHOPEDICS, LLC · Class I
- Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- SR Tip, Φ1.0mm, L 26mm — BIO CONCEPT Co., Ltd. · Class I
Cleared under the same submission
K152484 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 4624e321-20fc-4945-943b-7cc2de8553a0 35 fields · synced Jun 1, 2026