BIEDERMANN MOTECH GmbH & Co. KG
VS-SCHWENNINGEN Baden-Wurttemberg, DE
BIEDERMANN MOTECH GMBH & Co. KG appears in FDA device records in VS-SCHWENNINGEN Baden-Wurttemberg, DE. FDA records list 4 510(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 4 510(k) clearances for BIEDERMANN MOTECH GmbH & Co. KG between 2016 and 2021. The busiest year on record is 2016, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203607 | MOSS VRS Spinal System | NKB | Substantially Equivalent | |
| K181821 | MOSS VRS Spinal System | NKB | Substantially Equivalent | |
| K170890 | TELIX K Interbody System | MAX | Substantially Equivalent | |
| K162232 | MOSS 100 Pedicle Screw System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010944 | 3002806545 | BIEDERMANN MOTECH GMBH & Co. KG | BERTA-SUTTNER-STRASSE 23, VS-SCHWENNINGEN Baden-Wurttemberg D-78054 DE | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- HTDForceps
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- MDMInstrument, Manual, Surgical, General Use
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- HTOReamer
- GADRetractor
- HWCScrew, Fixation, Bone
- LRZScrewdriver, Surgical
- MQPSpinal Vertebral Body Replacement Device
- JDRStaple, Fixation, Bone
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- LRPTray, Surgical
- HTNWasher, Bolt Nut
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain