Identity
- Trade Name
- TRANSLACE™ Spinal Tethering System FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- TRAY 8239100 TRANSLACE INSTRUMENTS FDA UDI
- Model / Reference
- 8239100 FDA UDI
- Description
- TRAY 8239100 TRANSLACE INSTRUMENTS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169742949 FDA UDI
- 510(k) Number
- K163181 FDA UDI
- FDA Product Code
- OWI FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 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
No
FDA UDI
Over-the-Counter
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
TRANSLACE™ Spinal Tethering System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Cleared under the same submission
K163181 also covers:
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- Translace™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- Translace™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC.
- Translace™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI a9e9458e-4198-499a-9114-092dc83a06c3 35 fields · synced May 30, 2026