STERLING INTERFERENCE SCREW ST— 510(k) K050767
Substantially EquivalentRegeneration Technologies, Inc.
FDA 510(k) clearance K050767 for STERLING INTERFERENCE SCREW ST, Substantially Equivalent on 2005-06-09. Applicant: Regeneration Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Regeneration Technologies, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code HWC
view allMore clearances from Regeneration Technologies, Inc.
view all- K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- K072238 — BIOSET XCH
- K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
- K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
- K060180 — BIOSET XC
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.