Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Orthopaedic chisel blade FDA UDI
- Device Name
- ALVEOLAR RIDGE EXPANDING CHISEL 3MM 6"/15CM (SS 17-4) FDA UDI
- Model / Reference
- 4544701 FDA UDI
- Description
- ALVEOLAR RIDGE EXPANDING CHISEL 3MM 6"/15CM (SS 17-4) FDA UDI
Identifiers
- Catalog Number
- 4544701 FDA UDI
- Primary DI / UDI-DI
- 00614950030873 FDA UDI
- 510(k) Number
- K981526 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Orthopaedic chisel blade FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic chisel blade
Ace by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic chisel blade.
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- Buxton BioMedical — BUXTON BIOMEDICAL, INC. · Class I
- Intramedullary Internal Chisel — Biomet Orthopedics, Inc. · Class I
- GSO GS1 Spinal System — UNIFIED SPINE, LLC · Class I
Cleared under the same submission
K981526 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
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 4ea01b17-2c1d-49ab-a3bc-07fe7abd9a3f 36 fields · synced May 29, 2026