AAP IMPLANTATE AG

FDA Device Registration & Listing · BERLIN, DE · Registration 8043862

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043862
FEI Number
3001406084
Entity Name
AAP IMPLANTATE AG
City/State/Country
BERLIN, DE
Establishment Address
LORENZWEG 5, BERLIN 12099, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AAP IMPLANTATE AG (Owner Number: 9004207)
Owner / Operator Contact Address
LORENZWEG 5, --, BERLIN, DE-BE 12099, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cannulated Headless Bone Screws aap LOQTEQ Small Fragment Set APS TAP MULTIPLE-AAP TAP Instruments working with the Calcaneus system aap Calcaneus Plates and Screws AAP DEPTH GAUGE Screw Rack Surgical Instrument Tray DARCO HEADED SCREW Cannulated Screws APS System AAP COMPRESSION DEVICE LOQTEQ® Proximal Tibia Plates 3.5 aap Radius Set 2.5 including plates & screws LOQTEQ® VA Elbow Plates 2.7/3.5 System Bending Template Bending Iron LOQTEQ® Proximal Humerus Plate 3.5 System LOQTEQ® VA Distal Fibula Plate 2.7/3.5, 3/4/6/8/10 holes, right/left LOQTEQ® VA Distal Medial Tibia Plate 3.5, 3/4/6/8/10/12/14 holes, right/left LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5, 4/6/8/10/12/14/16 holes, right/left LOQTEQ® Distal Fibula Plate 3.5, right and left Washer Cancellous Screw 4, small head, L 10-90 mm aap LOQTEQ Distal Lateral Femur Plate 4.5 System AAP CHISEL aap Implantate AG APS DRIVING WRENCH AAP WRENCH aap LOQTEQ Proximal Lateral Tibia Plate 4.5 System LOQTEQ® VA Proximal Humerus Plate 3.5 LOQTEQ Distal Medial Tibia 3.5 System AAP Cannulated Screws Darco Headed Screws aap LOQTEQ(R) Olecranon Plate DRILL GUIDES Instruments used with the Foot System aap Foot Plate and Screw System AAP TWIST DRILL aap surgical instruments AAP FORCEPS Cannulated Screws 2 AAP Bone Plates and Screw Implants aap LOQTEQ® Osteotomy System APS DRILL REAMER MULTIPLE AAP REAMER LOQTEQ® VA Volar Distal Radius Plate 2.5, narrow/broad, XL long, right/left LOQTEQ® VA Cortical Screw 2.5, T8 LOQTEQ® VA Distal Radius L-Plate 2.5, right/left LOQTEQ® VA Distal Radius Straight Plate 2.5 LOQTEQ® VA Distal Ulna Hook Plate 2.5 LOQTEQ® VA Distal Ulna Plate 2.5 LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5, right/left, 2/3/5/7/11 holes aap LOQTEQ Large Fragment Set DRILL BITS aap Cortical Screws 3.5, 4.5 aap Screwdriver

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-06-11
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-06-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-21
HWX Tap, Bone Orthopedic Class 1 888.4540 1994-10-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-12
HTJ Gauge, Depth Orthopedic Class 1 888.4300 1994-10-03
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2008-02-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-27
HWN Instrument, Compression Orthopedic Class 1 888.4540 1994-10-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-07-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-03-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-03-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-06-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-06-07
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2012-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2016-11-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-21
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 1994-10-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-03-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-03-05
HXC Wrench Orthopedic Class 1 888.4540 1994-10-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-10-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-09-15
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2007-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-12
HTW Bit, Drill Orthopedic Class 1 888.4540 1994-10-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 1994-10-03
HTD Forceps General, Plastic Surgery Class 1 878.4800 1994-10-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-04-05
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2016-04-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-10-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-10-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-03-30
HTO Reamer Orthopedic Class 1 888.4540 1994-10-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-03-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-03-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-03-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2007-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-06
HXX Screwdriver Orthopedic Class 1 888.4540 1994-10-27

Official Correspondent

Rubino Di Girolamo

US Agent Details

Robert Chirico Email: a.reuter@aap.de Phone: (303) 5226606

Related Public Records

Same Entity

AAP IMPLANTATE 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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
3007125392 Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043862. Last updated year: 2026. Please use registration number 8043862 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.