PASS LP SPINAL SYSTEM— 510(k) K110497

Clearance details

Applicant

Medicrea International

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2011-02-22

Decision date

2011-09-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Round Rock, TX, US

• K162066 — Reliance Spinal Screw System2016-12-02
• K162801 — CastleLoc Spinal Fixation System2016-11-03
• K162143 — FixxSure® X-Link2016-09-23
• K161151 — Spinal fixation system2016-09-21
• K162189 — ANAX 5.5 Spinal System2016-08-30

• K220810 — Infinity OCT System and PASS OCT Spinal System2022-04-19
• K220724 — CD Horizon Spinal System and PASS LP Spinal System2022-04-08
• K180091 — UNiD Spine Analyzer2018-02-08
• K170172 — UNiD Spine Analyzer2017-05-24
• K153169 — PASS OCT Patient Specific Rods2016-01-29

Injury

978

Malfunction

793

Total

1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2458-2023 — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervicalClass II·Ongoing·Medicrea International·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110497.