RANGE SPINAL SYSTEM— 510(k) K121630

Unknown

K2m, Inc.

FDA 510(k) clearance K121630 for RANGE SPINAL SYSTEM, Unknown on 2012-09-11. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code OSH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2012-06-04
Decision date: 2012-09-11
Decision: Unknown
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSH

K153446 — OLYMPIC Posterior Spinal Fixation System2016-04-08
K140276 — CD HORIZON SPINAL SYSTEM2014-03-13
K132574 — PASS LP SPINAL SYSTEM2013-11-08
K132303 — IMPLANET SPINE SYSTEM2013-10-10
K132575 — PASS LP SPINAL SYSTEM2013-10-03

More clearances from K2m, Inc.

K260546 — Q Pedicle Instruments2026-03-17
K253545 — Vulcan Spinal System2026-02-10
K252873 — Q Interbody Instruments2026-02-06
K211320 — CAPRI Corpectomy Cage System2022-02-24
K202528 — Cannulated Power Driver Attachment2020-10-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.