Identity
- Trade Name
- P.L.U.S.® FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- ST 4.5mm X 30mm SCREW FDA UDI
- Model / Reference
- U1-S430 FDA UDI
- Description
- ST 4.5mm X 30mm SCREW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663136017181 FDA UDI
- 510(k) Number
- K021507 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
P.l.u.s.® by Spine Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K021507 also covers:
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, Inc.
- P.L.U.S.® — Spine Vision, 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 |
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Manufacturer
- Manufacturer
- Spine Vision, Inc.
Sources (1)
- FDA UDI caafe164-4b1c-45c6-9138-143ff53329d0 35 fields · synced May 31, 2026