K902332 is an FDA 510(k) clearance for the HALL MODULAR ACETABULAR REAMER SYSTEM. This device is classified as a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I - General Controls, product code HWE).
Submitted by Zimmer, Inc. (Carpinteria, US). The FDA issued a Cleared decision on June 25, 1990, 32 days after receiving the submission on May 24, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K902332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1990 |
| Decision Date | June 25, 1990 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |