Identity
- Trade Name
- TRUFIX Bone Fixation System FDA UDI
- Generic Name
- Orthodontic anchor plate FDA UDI
- Device Name
- * SURGICAL BONE PLATE L SHAPE 4-HOLE LEFT LONG 24TL .6MM THICK FDA UDI
- Model / Reference
- 45427401 FDA UDI
- Description
- * SURGICAL BONE PLATE L SHAPE 4-HOLE LEFT LONG 24TL .6MM THICK FDA UDI
Identifiers
- Catalog Number
- 45427401 FDA UDI
- Primary DI / UDI-DI
- 00614950006083 FDA UDI
- 510(k) Number
- K951392 FDA UDI
- FDA Product Code
- OAT FDA UDI
- GMDN Term
- Orthodontic anchor plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Millimeter FDA UDI
Category: Orthodontic anchor plate
TRUFIX Bone Fixation System by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic anchor plate.
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class II
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class II
- MATRIXWAVE — Synthes · Class II
- PENDING — MEDLINE INDUSTRIES, INC. · Class II
- NEOFACE — Neoortho Produtos Ortopédicos S/A. · Class II
Cleared under the same submission
K951392 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
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
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI d455e550-7b95-42d7-8090-9728b7ab1064 37 fields · synced Jun 1, 2026