Identity
- Trade Name
- Translace™ Spinal Tethering System FDA UDI
- Generic Name
- Surgical support tape, non-bioabsorbable FDA UDI
- Device Name
- TETHER 9010007012 0.2MM INSERT ASSEMBLY FDA UDI
- Model / Reference
- 9010007012 FDA UDI
- Description
- TETHER 9010007012 0.2MM INSERT ASSEMBLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000333386 FDA UDI
- 510(k) Number
- K163181 FDA UDI
- FDA Product Code
- OWI FDA UDI
- GMDN Term
- Surgical support tape, non-bioabsorbable 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical support tape, non-bioabsorbable
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 Surgical support tape, non-bioabsorbable.
- Pitch-Patch 35 mm x 25 mm — XIROS LTD · Class II
- Axiom® Lig-A-Loops® — AXIOM MEDICAL, INCORPORATED · Class I
- Axiom® Lig-A-Loops® — AXIOM MEDICAL, INCORPORATED · Class I
- Bard® PTFE Braided Tape — Bard Peripheral Vascular · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Infinity-Lock 5 — XIROS LTD · Class II
- Arthrex® — Arthrex, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 377be763-85cb-4dff-ad53-67297d6d7c0a 36 fields · synced May 31, 2026