Data / Medical devices / United States / Brasseler U.S.A. Medical, LLC
Brasseler U.S.A. Medical, LLC: FDA-registered device maker in Savannah, GA, United States, 11 510(k) clearances
Brasseler U.S.A. Medical, LLC is registered with the FDA (registration 2025102) in Savannah, GA, United States. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 3, 2003. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025102
- FEI number
- 3004949275
- Address
- 1 Brasseler Blvd, Savannah, GA, United States, 31419
- Owner or operator
- Brasseler U.S.A. Medical, LLC (9010748)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 21, 1994
- Registered through
- 2026
- Brand names listed
- Arthrex Large Bone Sagittal Blade, Axiom Slap Hammer, BRASSELER BLADE, SAW, SURGICAL CARDIOVASCULAR, BRASSELER BUR, SURGICAL, GENERAL & PLASTIC SURGERY SURGICAL, BRASSELER BURR, ORTHOPEDIC, BRASSELER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED), BRASSELER Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment, BRASSELER LAVAGE JET and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2003 | K030172 | SMALL HIGH SPEED MOTOR DRILL SYSTEM | HBE | Substantially Equivalent | Brasseler USA I, L.P. | accessdata.fda.gov |
| January 14, 1999 | K983223 | DENTAL STERLIZATION TRAY/CASSETTE | FRG | Substantially Equivalent | Brasseler USA I, L.P. | accessdata.fda.gov |
| June 20, 1997 | K970916 | H.V. PULSE LAVAGE (L31 SERIES) | FQH | Substantially Equivalent | Global Medical Products, Inc. | accessdata.fda.gov |
| March 7, 1995 | K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS | JDW | Substantially Equivalent | Brasseler USA I, L.P. | accessdata.fda.gov |
| August 22, 1994 | K943758 | SURGICAL BUR | GFF | Substantially Equivalent | Komet Medical | accessdata.fda.gov |
| April 21, 1994 | K935367 | TAVA WIRE-DRIVER | HSZ | Substantially Equivalent | Tava Surgical Instruments | accessdata.fda.gov |
| February 22, 1994 | K940109 | TAVA K-WIRE | HTY | Substantially Equivalent | Tava Surgical Instruments | accessdata.fda.gov |
| September 15, 1988 | K883255 | KOMET SURGICAL BUR | GFF | Substantially Equivalent | Komet Medical, Div. of Brasseler USA I, L.P. | accessdata.fda.gov |
| July 2, 1987 | K872475 | SURGICAL BUR | GFF | Substantially Equivalent | Tava Surgical Instruments | accessdata.fda.gov |
| October 14, 1986 | K863788 | SAWBLADE | GFA | Substantially Equivalent | Tava Surgical Instruments | accessdata.fda.gov |
| January 27, 1986 | K854543 | PULSE LAVAGE | FQH | Substantially Equivalent | Tava Surgical Instruments | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 28, 2022 | 89555 | Class II | Terminated | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S | One lot of product was distributed in unsealed packaging | accessdata.fda.gov |
| December 11, 2019 | 84545 | Class II | Terminated | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. | 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins. | accessdata.fda.gov |
| October 18, 2019 | 84177 | Class II | Terminated | 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. | One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Blade, Saw, Surgical, Cardiovascular
- All makers of Burr, Orthopedic
- All makers of Wrap, Sterilization
- All makers of Saw, Pneumatically Powered
- All makers of Bur, Surgical, General & Plastic Surgery
- All makers of Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Updated April 3, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.