ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)— 510(k) K083654
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K083654 for ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM), Substantially Equivalent on 2009-02-26. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, 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
- Special
- Location
- Warsaw, IN, US
Recent devices under product code HRS
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
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 →
Recalls naming K083654
K-number listed on FDA's recall record- Z-0312-2020 — Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 47492801802 47492801813 47492801902 47492802002 47492802013 47493600313 47493600403 47493600407 47493600413 47493600503 47493600507 47493600513 47493600603 47493600607 47493600613 47493600703 47493600707 47493600713 47493600803 47493600807 47493600813 47493600907 47493600913 47493601003 47493601007 47493601013 47493601113 47493601203 47493601207 47493601213 47493601313 47493601403 47493601407 47493601413 47493601513 47493601607 47493601613 47493601813 47493602007 47493602013 47493602213 47493603305 47493603306 47493603405 47493603406 47493603504 47493604604 47493800303 47493800402 47493800502 47493800603 47493800613 47493800702 47493800703 47493800802 47493800803 47493800902 47494600403 47494600407 47494600413 47494600503 47494600507 47494600513 47494600603 47494600607 47494600613 47494600703 47494600707 47494600713 47494600803 47494600807 47494600813 47494600913 47494601003 47494601013 47494601113 47494601203 47494601213 47494603305 47494603306 47494603405 47494603406 47494603504 47494604604
- Z-1041-2014 — 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083654.
Data sourced from openFDA. This site is unofficial and independent of the FDA.