ZIMMER POROLOCK MIS STEM— 510(k) K071723
Substantially EquivalentZimmer GmbH
FDA 510(k) clearance K071723 for ZIMMER POROLOCK MIS STEM, Substantially Equivalent on 2008-03-07. Applicant: Zimmer GmbH. Device class: 3.
Clearance details
- Applicant
- Zimmer GmbH
- Product code
- Code KWA
- Device class
- Class 3
- Regulation
- 21 CFR 888.3330
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KWA
view allMore clearances from Zimmer GmbH
view allAdverse events under product code KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071723
K-number listed on FDA's recall record- Z-0320-2020 — Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210 0100551211 0100551212 0100551213 0100551214 0100551301 0100551302 0100551303 0100551304 0100551305 0100551306 0100551307 0100551308 0100551309 0100551310 0100551311 0100551312 0100551313 0100551314 0100551401 0100551402 0100551403 0100551404 0100551405 0100551406 0100551407 0100551408 0100551409 0100551410 0100551411 0100551412 0100551413 0100551414
- Z-0220-2013 — Fitmore" Hip Stem
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071723.
Data sourced from openFDA. This site is unofficial and independent of the FDA.