Identity
- Trade Name
- Calvary Spine Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Locking Cap FDA UDI
- Model / Reference
- 1001 FDA UDI
- Description
- Locking Cap FDA UDI
Identifiers
- Catalog Number
- 1001 FDA UDI
- Primary DI / UDI-DI
- B11410010 FDA UDI
- 510(k) Number
- K201568 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone set screw 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 set screw
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 set screw.
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- SET SCREW — OsteoCentric Technologies,Inc · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
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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 50221070-cbca-4d02-83d0-92f862b6fb10 35 fields · synced May 30, 2026