Identity
- Trade Name
- Vu a-POD™ FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- 27x21 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage. FDA UDI
- Model / Reference
- 21-11-2712 FDA UDI
- Description
- 27x21 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage. FDA UDI
Identifiers
- Catalog Number
- 21-11-2712 FDA UDI
- Primary DI / UDI-DI
- 10889981037727 FDA UDI
- 510(k) Number
- K080822 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Vu a-POD™ by SeaSpine Orthopedics Corporation — 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
K080822 also covers:
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
- Vu a-POD™ — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 269a23c6-c2c0-4d44-8f87-3e0682f811bb 37 fields · synced Jun 8, 2026