Identity
- Trade Name
- Vital Spinal Fixation System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Rod Connector, Lateral, 4 Screw, Closed, Large, 5.5/6.0 FDA UDI
- Model / Reference
- 710M1356 FDA UDI
- Description
- Rod Connector, Lateral, 4 Screw, Closed, Large, 5.5/6.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662663063104 FDA UDI
- 510(k) Number
- K230116 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Vital Spinal Fixation System by Zimmer Biomet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K230116 also covers:
- Vital™ Spinal Fixation System — Highridge Medical, LLC
- Vital™ Spinal Fixation System — Highridge Medical, LLC
- Vital Spinal Fixation System — Zimmer Biomet
- Vital Spinal Fixation System — Zimmer Biomet
- Vital Spinal Fixation System — Zimmer Biomet
- Vital Spinal Fixation System — Zimmer Biomet
- Vital Spinal Fixation System — Zimmer Biomet
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
- Zimmer Biomet
Sources (1)
- FDA UDI eb7f27c4-c086-44dd-bada-91b4f37df718 34 fields · synced May 31, 2026