Identity
- Trade Name
- JAZZ System FDA UDI
- Generic Name
- Internal spinal fixation system cable tensioner FDA UDI
- Device Name
- Tensioner Gen. II - 90° Stem FDA UDI
- Model / Reference
- Tensioner Gen. II - 90° Stem FDA UDI
- Description
- Tensioner Gen. II - 90° Stem FDA UDI
Identifiers
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
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 90 degree FDA UDI
Category: Internal spinal fixation system cable tensioner
JAZZ System by Implanet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal spinal fixation system cable tensioner.
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Mariner Cap — SeaSpine Orthopedics Corporation · Class II
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- TRANSLACE™ Spinal Tethering System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Mariner Cap — SeaSpine Orthopedics Corporation · Class II
Cleared under the same submission
K151740 also covers:
K160226 also covers:
K170730 also covers:
K171881 also covers:
K182771 also covers:
K191217 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
- Implanet
Sources (1)
- FDA UDI cdb0dd90-3b70-4d8b-b5d2-108613a7f347 36 fields · synced Jun 1, 2026