ANSPACH MINI-PLATING SYSTEM— 510(k) K921338
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K921338 for ANSPACH MINI-PLATING SYSTEM, Substantially Equivalent on 1993-02-10. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Park, FL, US
Recent devices under product code HRS
view allMore clearances from The Anspach Effort, Inc.
view all- K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
- K183545 — Anspach Helix Dissection Tools
- K180063 — OCM-G1 Attachment
- K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
- K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.