Identity
- Trade Name
- Calvary Spine Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Polyaxial Screw 5.5mm Diameter 35mm length FDA UDI
- Model / Reference
- 15535 FDA UDI
- Description
- Polyaxial Screw 5.5mm Diameter 35mm length FDA UDI
Identifiers
- Catalog Number
- 15545 FDA UDI
- Primary DI / UDI-DI
- B114155350 FDA UDI
- 510(k) Number
- K201568 FDA UDI
- FDA Product Code
- NKB 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
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
MR Conditional FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Calvary Spine Pedicle Screw System by Calvary Spine, Llc — 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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- 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
K201568 also covers:
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
- Calvary Spine Pedicle Screw System — CALVARY SPINE, LLC
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
- Calvary Spine, Llc
Sources (1)
- FDA UDI c99cc711-7a23-4d7e-addb-071ee978b492 35 fields · synced May 30, 2026