Data / Medical devices / United States / Calvary Spine, LLC
Calvary Spine, LLC: FDA-registered device maker in Towson, MD, United States, 2 510(k) clearances
Calvary Spine, LLC is registered with the FDA (registration 3007279845) in Towson, MD, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 12, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007279845
- Address
- 308 North Wind Rd., Towson, MD, United States, 21204
- Owner or operator
- Calvary Spine, LLC (10027607)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 19, 2008
- Registered through
- 2027
- Brand names listed
- 23mm, 24mm, 25mm, 26mm, 27mm, 28mm Fixed Crosslinks, Calvary Cervical Interbody Spacers/ Fusion Device (standard & large footprint interbody cages; 5-9mm heights), Calvary Lumbar Interbody Spacers/ Fusion Device (crescent & straight-shaped interbody cages; 7-15mm heights), Calvary Spine Pedicle Screw System, Cervical Instruments: 5-9mm trials, 5-9mm dual head trials, rasp, tamp, mallet, inserter, caddy, instrument tray & lid, Extra Small, Small, Medium, and Large Variable Crosslinks, Iliac Connector 5.5mm Diameter 30mm & 50 mm rod lengths, Locking cap for Polyaxial screws and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2020 | K201568 | Calvary Spine Pedicle Screw System | NKB | Substantially Equivalent | Calvary Spine, LLC | accessdata.fda.gov |
| October 17, 2008 | K082260 | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES | MAX | Substantially Equivalent | Calvary Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated November 12, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.