Identity
- Trade Name
- Template for A-4851.26 EUDAMEDAPTUS FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Templates EUDAMEDTemplate for A-4851.26 FDA UDI
- Model / Reference
- A-4851.26TP EUDAMEDFDA UDI
- Description
- Template for A-4851.26 FDA UDI
Identifiers
- Catalog Number
- A-4851.26TP FDA UDI
- Primary DI / UDI-DI
- 07630894815843 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378005PA EUDAMED
- 510(k) Number
- K192984 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical implant template, reusable
A comprehensive template for surgical implant placement, designed to determine the appropriate size and placement of a non-dental implant for patients prior to or during surgery. It is typically available as a graduated set or an individual plate with patterns/sizes corresponding to the size of the implant.
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K192984 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 91516b01-23d6-472a-bba0-8aa8c90bddbd 35 fields · synced Jul 13, 2026
- EUDAMED ca29f085-caf8-479a-82e4-5cdb3213f28d 61 fields · synced Jul 13, 2026