Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007441485

FEI Number

3007441485

Entity Name

MOSER-BAER AG

City/State/Country

Sumiswald Bern, CH

Establishment Address

Spitalstrasse, Sumiswald Bern 3454, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Moser-Baer AG (Owner Number: 10048610)

Owner / Operator Contact Address

Spitalstrasse, Sumiswald, CH-BE 3454, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pelvic / Handle / Thoracic / Loading Base Positioner TFX Blanc Flex Shaft Silo TFX Simplified Inserter Quick Adjust Struts Targeting Device for intramedullary nail screw placement Hub Connector Standard, Narrow, Split Blade Blade / Standard / Reverse / Wide Double Arm Assembly Zimmer Biomet Drill Cannulated, Navigation Awl Adjustable Depth AWL TKA1.4 ZIP SIZER/DISTRACTOR Aiming Arm Anatomical Shoulder Assembly block 014558.108 Anatomical Shoulder Fracture Assembly block / Adapter, 014558.122 Anatomical Shoulder Revision Screw II - Connector I, 014558.310 Anatomical Shoulder Reamer for humeral stem 6, 014558.105 Anatomical Shoulder Revision Screw I - Connector I, 014558.309 Anatomical Shoulder Reamer for humeral stem 16, 014558.106 Anatomical Shoulder Reamer for humeral stem 18, 014558.107 Anatomical Shoulder Revision Screw III - Connector II / III, 014558.311 Anatomical Shoulder Reamer for humeral stem 5, 014558.104 ADJUSTABLE / OCCIPITAL Drill, Tap, Screwdriver Integrated Suction long / short Aiming Arm ROSA PARTIAL KNEE SYSTEM Probe straight, duckbill Mercury N Driver Cannulated Adjustable Depth Tap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-09-08
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-12-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-02-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-01-10
HWT	Template	Orthopedic	Class 1	888.4800	2025-04-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-01-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-03-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-02-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-06-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2022-01-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2015-08-31
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-08-31
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-08-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-06-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-03-31
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-07-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-10-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-02-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-02-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-02-27
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2024-07-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-07-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-12
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-11-10
QWL	Intraoperative Surgical Angle Measurement Tool	Orthopedic	Class 2	888.4560	2025-07-18
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-03-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-03-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2015-03-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-03-10
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2026-04-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-22
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-12-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-02-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-02-21
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-02-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-02-02
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-03-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-11-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-11-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-04-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-12-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-22
QWL	Intraoperative Surgical Angle Measurement Tool	Orthopedic	Class 2	888.4560	2024-10-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-08-18
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2022-08-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-01-16
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-03-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-03-06

Official Correspondent

Reto Reist

US Agent Details

Sarah Strassburger Email: sstrass@icloud.com Phone: (260) 4467411

Related Public Records

Same Entity

Moser-Baer AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007441485. Last updated year: 2026. Please use registration number 3007441485 when referencing this establishment in official correspondence.