Identity
- Trade Name
- PER System 50 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- PER System 50 FDA UDI
- Model / Reference
- 89012 FDA UDI
- Description
- PER System 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115935332 FDA UDI
- 510(k) Number
- K232719 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod 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
Category: Bone-screw internal spinal fixation system rod
PER System 50 by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K232719 also covers:
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- PER System 60 — PREMIA SPINE LTD
- PER System 75 — PREMIA SPINE LTD
- Ring Nut Loading Base — PREMIA SPINE LTD
- Rod Holding Forceps Self Retaining — PREMIA SPINE LTD
- Rod Length Measurement Tool — PREMIA SPINE LTD
- Rod Pusher — PREMIA SPINE LTD
- VersaLink Torque Limiter — PREMIA SPINE LTD
- Versalink Nut Counter Torque — 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 |
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Manufacturer
- Manufacturer
- Premia Spine Ltd
Sources (1)
- FDA UDI c15685b8-b5ba-45e9-a360-cf5261bfa556 35 fields · synced May 30, 2026