Data / Medical devices / United States / Integrity Spine
Integrity Spine: FDA-registered device maker in San Antonio, TX, United States, 2 510(k) clearances
Integrity Spine is registered with the FDA (registration 3010763958) in San Antonio, TX, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 10, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010763958
- Address
- 414 W Sunset Rd Ste 205, San Antonio, TX, United States, 78209
- Owner or operator
- Integrity Spine (10046086)
- Roles
- Manufacturer
- First device listed
- January 31, 2014
- Registered through
- 2026
- Brand names listed
- Intervertebral fusion device with bone graft, cervical, Intervertebral fusion device with bone graft, lumbar, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, Rasp, Tamp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer | 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 10, 2015 | K151819 | Integrity Spine Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Integrity Spine Lumbar Interbody Fusion System | accessdata.fda.gov |
| November 18, 2013 | K132718 | INTEGRITY SPINE CORE SYSTEM | ODP | Substantially Equivalent | Integrity Spine | accessdata.fda.gov |
Compare with other makers
- All makers of Tamp
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Rasp
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated November 10, 2015. 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.