Home › Device types › HTR
Rasp
FDA product code HTR · Class 1 · General, Plastic Surgery
4,773
Registered devices
287
Adverse events
2
Recalls
9
510(k) clearances
Devices with this code
N/A — BLACK & BLACK SURGICAL, INC.Calix Spinal Implant System — Xtant Medical Holdings, Inc.Calix Spinal Implant System — Xtant Medical Holdings, Inc.Irix-C Cervical Integrated Fusion System — Xtant Medical Holdings, Inc.Specials — Seaspine Orthopedics CorporationNA — Zimmer, Inc.Surgical Instrument — Jeil Medical CorporationStryker — Avalign Technologies, Inc.Specials — Seaspine Orthopedics CorporationGENERIC Surgical Instruments — CTL Medical CorporationIrix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc.C-THRU Anterior Spinal Spacer System — Highridge Medical, LLCL-Box® — INNO Holdings, Inc.Legion — Smith & Nephew, Inc.Tranquil-C™ — NEXUS SPINE, L.L.C.EXACT(TM) CALCAR PLANER — Biomet Orthopedics, LLCIrix-C Cervical Integrated Fusion System — Xtant Medical Holdings, Inc.Tranquil-C™ — NEXUS SPINE, L.L.C.TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.Mergence-S Spinal Instrumentation System — Highridge Medical, LLCC-Box® — INNO Holdings, Inc.Meridian — Seaspine Orthopedics CorporationIdentiTi — ALPHATEC SPINE, INC.COLUMBUS REVISION — Aesculap AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted becau |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
