Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016237080

FEI Number

3016237080

Entity Name

PTUMEDICAL GMBH

City/State/Country

Spaichingen Baden-Wurttemberg, DE

Establishment Address

Hermann-Winker-Str. 7, Spaichingen Baden-Wurttemberg 78549, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PTUmedical GmbH (Owner Number: 10062025)

Owner / Operator Contact Address

Hermann-Winker-Str. 7, Spaichingen, DE-BW 78549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-04-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-12-12
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2022-04-25
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-12-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-12-13
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-02-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-09-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-06-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-08-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-08-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-17
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-01-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-17
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2024-01-11
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-04-01
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-08-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-06-10
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2021-02-02
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-11-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-27
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-12
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-12-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-02-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-02-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-03-16
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-03-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-01-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-02-06
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-08-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-01
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-04-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-12

Official Correspondent

Tevfik Uzun

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

PTUmedical GmbH

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
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
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016237080. Last updated year: 2026. Please use registration number 3016237080 when referencing this establishment in official correspondence.