Identity
- Trade Name
- Vu a-POD™ FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- 27x21mm Trial 8mm 8 deg. 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
- 21-20-2708 FDA UDI
- Description
- 27x21mm Trial 8mm 8 deg. 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
- 21-20-2708 FDA UDI
- Primary DI / UDI-DI
- 10889981037888 FDA UDI
- 510(k) Number
- K080822 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal implant trial 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: Spinal implant trial
Vu a-POD™ by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal implant trial.
- Novel — ALPHATEC SPINE, INC. · Class II
- Scarlet AL-T Instruments — Spineart · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- MLX — Nuvasive, Inc. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- ROI-A — Ldr Spine USA · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI ac6221fb-e524-44de-9b06-e3ac3a3b5c1b 37 fields · synced Jun 8, 2026