Panels › General, Plastic Surgery › Product code GFA · Class 1
Blade, Saw, General & Plastic Surgery, Surgical
Regulation 878.4820
0510(k)s in 12 months (27 all time)
0recalls in 12 months (19 all time)
2recalls that name a 510(k)
Top companies in GFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 0 | 4 |
| Micro-Aire Surgical Instruments, Inc. | 4 | 0 |
| Synvasive Technology Inc | 0 | 3 |
| Terumo Cardiovascular Systems Corporation | 0 | 3 |
| Boehringer Laboratories | 2 | 0 |
| Linvatec Corp. dba ConMed Linvatec | 0 | 2 |
| Omega Surgical Instruments, Inc. | 2 | 0 |
| Wrightmedicaltechnologyinc | 2 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| Adven Medical | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number.
a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS;
b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Num Open, Classified |
GFA | None listed |
| Mar 19, 2019 | Stryker Instruments Div. of Stryker Corporation Performance Series Sagittal Blade, Catalog Number 6125-127-100
Product Usage:
The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in vario Terminated |
GFA | None listed |
| Jul 27, 2018 | Synvasive Technology Inc ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures.
Manufactured By:
Synvasive Technology, Inc., a Subsidiary of Zimmer Terminated |
GFA | None listed |
| Dec 8, 2015 | Synvasive Technology Inc Zimmer Oscillating Flat - TS ST Hub;
75mm x 19mm x 1.00/1.27mm;
Synvasive Part No. 11-4770:
Part No. 19075127YT1;
Lot No. 45104 and 43054
Description: STRYK_76542K_19X75X1.27T
General and Plasti Terminated |
GFA | None listed |
| Oct 14, 2015 | Stryker Sustainability Solutions SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades
Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help th Terminated |
GFA | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447
- Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lo Terminated |
GFA | None listed |
| Apr 15, 2013 | Synvasive Technology Inc Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA
Reciprocating saw blade: A ste Terminated |
GFA | None listed |
| Jun 25, 2012 | Stryker Endoscopy Formula Shaver Handpiece (with buttons);
Formula 180 Shaver Handpiece (with button)
Rx only, Made USA.:
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138
Components within the Crossfire System Terminated |
GFA | None listed |
| Feb 10, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Terminated |
GFA | None listed |
| Jul 12, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY
For Functional Endoscop Terminated |
GFA | None listed |
| Jan 26, 2011 | Terumo Cardiovascular Systems Corporation Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI.
The sternal saw blades are indicated for use in medial sternotomo Terminated |
GFA | K935391 |
| Sep 25, 2010 | Linvatec Corp. dba ConMed Linvatec GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only. Terminated |
GFA | None listed |
| Jan 13, 2009 | Sterilmed Inc Saw Blade
Model #'s:
BIO506112
BIO506113
DEP2555-91-000
DEP5627-11-500
HAL5023-118
HAL5059-32
HAL5071-133
HAL5071-145
HAL5071-163
HAL5071-181
HAL5071-572
HOWHB-NST-6828-7-791
HOWHB-NST-6828-7-792
KOM Terminated |
GFA | None listed |
| Dec 2, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S.
Indicated for use in medial Terminated |
GFA | K935391 |
| Dec 2, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670.
Indicated for use in medial sternotomies. The Sarns Sternal Saw II system Terminated |
GFA | None listed |
| Sep 29, 2008 | Biomet, Inc. Exact Calcar Planer Rasp Style Blade, 50mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473798. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat Terminated |
GFA | None listed |
| Sep 29, 2008 | Biomet, Inc. Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat Terminated |
GFA | None listed |
| Sep 29, 2008 | Biomet, Inc. Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat Terminated |
GFA | None listed |
| Sep 29, 2008 | Biomet, Inc. Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat Terminated |
GFA | None listed |
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