Identity
- Trade Name
- Calvary Spine Pedicle Screw System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- PreLordosed Rod 5.5mm Diameter 50mm length Ti6Al4V FDA UDI
- Model / Reference
- 550 FDA UDI
- Description
- PreLordosed Rod 5.5mm Diameter 50mm length Ti6Al4V FDA UDI
Identifiers
- Catalog Number
- 550 FDA UDI
- Primary DI / UDI-DI
- B1145500 FDA UDI
- 510(k) Number
- K201568 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
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: Bone-screw internal spinal fixation system rod
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 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
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 a7812986-9958-460d-9697-7224369e01b7 35 fields · synced May 30, 2026