STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.— 510(k) K060253
Substantially EquivalentRegeneration Technologies, Inc.
FDA 510(k) clearance K060253 for STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST., Substantially Equivalent on 2006-02-23. 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
- Special
- Location
- Alachua, FL, US
Recent devices under product code HWC
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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.