MedTech LLC
Millington, TN, US
MEDTECH LLC appears in FDA device records in Millington, TN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for MedTech LLC between 1999 and 2020. The busiest year on record is 2019, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2009 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200511 | ROSA ONE Brain application | HAW | Substantially Equivalent | |
| K192173 | ROSA ONE Spine application | OLO | Substantially Equivalent | |
| K182848 | ROSA ONE Spine application | OLO | Substantially Equivalent | |
| K182417 | ROSA ONE Brain Application | HAW | Substantially Equivalent | |
| K172444 | ROSA BRAIN (v3.0.0.5) | HAW | Substantially Equivalent | |
| K151511 | ROSA Spine | OLO | Substantially Equivalent | |
| K151359 | ROSA Brain | HAW | Substantially Equivalent | |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | HAW | Substantially Equivalent | |
| K990663 | INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010123256 | 3010123256 | MEDTECH LLC | 8022 Martha Rd, Millington, TN 38053 US | 2026 | and 48 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- GESBlade, Scalpel
- HTQBroach
- HTTBurr, Orthopedic
- FZOChisel, Surgical, Manual
- HTFCurette
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- HWRDriver, Prosthesis
- HTEElevator
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- GCJLaparoscope, General & Plastic Surgery
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HRSPlate, Fixation, Bone
- KILPositioner, Socket
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HTRRasp
- HTOReamer
- GADRetractor
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- JDRStaple, Fixation, Bone
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HWKTrephine
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain