Data / Medical devices / United States / Intelivation Technologies, LLC
Intelivation Technologies, LLC: FDA-registered device maker in Plymouth Meeting, PA, United States, 6 510(k) clearances
Intelivation Technologies, LLC is registered with the FDA (registration 3019356409) in Plymouth Meeting, PA, United States. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019356409
- Address
- 500 S Gravers Rd Suite 200, Plymouth Meeting, PA, United States, 19462
- Owner or operator
- Intelivation Technologies LLC. (10081899)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 4, 2021
- Registered through
- 2026
- Brand names listed
- AOL-200 Advantage Lumbar Expandable Disc Shaver, Advantage Lumbar- ALIF, PLIF, DLIF, TLIF, Advantage-C, Advantage-C Inserter, Advantage-C PEEK Cervical Interbody Fusion Device, Advantage-C Rasp, Advantage-C Tamp, Advantage-C Trial and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Halter, Head, Traction | HSS | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 14, 2023 | K231147 | Hammerdesis Interphalangeal Fusion System | HTY | Substantially Equivalent | Intelivation | accessdata.fda.gov |
| October 29, 2021 | K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | MAX | Substantially Equivalent | Intelivation, LLC | accessdata.fda.gov |
| August 24, 2021 | K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | ODP | Substantially Equivalent | Lntelivation, LLC | accessdata.fda.gov |
| August 19, 2021 | K212185 | Golden Isles Pedicle Screw System | NKB | Substantially Equivalent | Intelivation, LLC | accessdata.fda.gov |
| August 21, 2006 | K061798 | BIOPRO MEMORY STAPLE | JDR | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012990 | COLLATEK POWDER | KGN | Substantially Equivalent | Biocore Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Fixation, Bone
- All makers of Bender
- All makers of Blade, Scalpel
- All makers of Tamp
- All makers of Reamer
- All makers of Gauge, Depth
Updated September 14, 2023. 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.