Identity
- Trade Name
- Polyaxial Pedicle Screw FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x40 mm FDA UDI
- Model / Reference
- 86130 FDA UDI
- Description
- Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x40 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290014064874 FDA UDI
- 510(k) Number
- K150380 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDINKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6.5 Millimeter FDA UDILength — 40 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Polyaxial Pedicle Screw by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K150380 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
- Head Releaser — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA — PREMIA SPINE LTD
- MIS Cannulated Pedicle Probe — PREMIA SPINE LTD
- MIS Compressor — PREMIA SPINE LTD
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
- Premia Spine Ltd
Sources (1)
- FDA UDI 6b19cf22-62a5-428d-bea9-69ef9f808bb2 36 fields · synced Jun 1, 2026