Panels › General, Plastic Surgery › Product code GFF · Class 1
Bur, Surgical, General & Plastic Surgery
Regulation 878.4820
0510(k)s in 12 months (16 all time)
0recalls in 12 months (13 all time)
4recalls that name a 510(k)
Top companies in GFF
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 1 | 3 |
| Micro-Aire Surgical Instruments, Inc. | 4 | 0 |
| Acumed Instruments Corp. | 1 | 0 |
| American Medical Specialties, Inc. | 1 | 0 |
| Arthrex, Inc. | 0 | 1 |
| Brasseler USA I Lp | 0 | 1 |
| ConMed Corporation | 0 | 1 |
| Danek Medical, Inc. | 1 | 0 |
| EXP Pharmaceutical Services Corp | 0 | 1 |
| In2Bones, SAS | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2021 | In2Bones, SAS In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. Terminated |
GFF | None listed |
| Oct 18, 2019 | Brasseler USA I Lp BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries. Terminated |
GFF | K872475 |
| Jan 14, 2019 | Arthrex, Inc. Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT)
These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedur Terminated |
GFF | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 Terminated |
GFF | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 19cm Attachment, Black Max
Product Usage:
Pneumatic system Terminated |
GFF | K974025 |
| May 31, 2016 | ConMed Corporation Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number Terminated |
GFF | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number A-CRN-S;
EXP (repackager), Anspach (OEM)
Bur, surgical, general Terminated |
GFF | None listed |
| Jan 27, 2014 | The Anspach Effort, Inc. Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only
Single use Sterile bone cutting burs. Terminated |
GFF | K011444 K974025 |
| Jan 6, 2014 | The Anspach Effort, Inc. Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.
Cutting and shaping bone. Terminated |
GFF | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665
- Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannula Terminated |
GFF | None listed |
| Jan 13, 2009 | Sterilmed Inc Burrs
Model #'s:
ANSL-3SB
ANSL-5D
ANSQD11-4OVDC
HAL5056-118
HAL5056-166
HAL5091-106
HAL5091-112
HAL5091-122
HAL5091-125
HAL5091-136
HAL5091-144
HAL5091-164
HAL5092-120
HAL5092-168
HAL5092-170
KOM04- Terminated |
GFF | None listed |
| Apr 8, 2008 | Linvatec Corp. ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773 Terminated |
GFF | K781979 |
| Jul 20, 2004 | Medtronic Xomed, Inc. Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070 Terminated |
GFF | None listed |
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