STREIFENEDER ortho.production gmbH

FDA Device Registration & Listing · EMMERING Bavaria, DE · Registration 8010401

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
8010401
FEI Number
5812
Entity Name
STREIFENEDER ortho.production gmbH
City/State/Country
EMMERING Bavaria, DE
Establishment Address
MOOSFELDSTRASSE 10, EMMERING Bavaria 82275, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Streifeneder ortho.production GmbH (Owner Number: 8010401)
Owner / Operator Contact Address
MOOSFELDSTRASSE 10, --, EMMERING, DE-BY 82275, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KINEGEN.air Modular 4-Bar Linkage Knee Joint Modular Single Axis Knee Joint Polycentric Knee Joint with hydraulic swing phase control Modular Knee Joint with Lock Rotation Adapter Tube Clamp Adapter Clutch-Lock 301 -Plastic- Clutch-Lock 151 -Aluminum- Clutch-Lock 401 -Aluminum- Brake Knee Joint with Pneumatic Swing Phase Control Polycentric Knee Joint with pneumatic swing Shuttle-Lock 402 -Aluminum- Shuttle-Lock 202 -Aluminum- Brake Knee Joint with lock Easy-Lock 103 Modular Brake Knee Joint Slide.fit - Slip-on aid Modular Knee Joint KINEGEN.air active KINEGEN.stream Modular Light Weight Knee Joint KINEGEN.basic KINEGEN.guard KINEGEN.smart Shuttle-Lock 302 -Plastic- Easy-Lock 153 -Aluminum- Easy-Lock 303 -Plastic- Double Adapter Clutch-Lock 501 -Aluminum- Clutch-Lock 101 -Plastic- Socket Attachment Block Easy-Lock 403 -Aluminum- Socket Adapter Easy-Lock 503 -Aluminum- Slip-on aid for knee prostheses Slide Adapter Shuttle-Lock 502 -Aluminum- Modular Extension Assist Easy-Lock 203 -Aluminum- Connection Adapter Shuttle-Lock 102 -Plastic- Shuttle-Lock 152 -Aluminum- Clutch-Lock 201 -Aluminum- Artikon.junior-Knee Joint Bars, bar width 12 mm, 14 mm or 16 mm Knee Brace, straight, Knee Orthosis for immobilisation GenuSupport.frontal - Hard Frame Knee Orthosis GenuSupport Vario-Test Tube, only trial purpose -Aluminum- Sliding Plate for modular prostheses -Aluminum- Adjusting Device for modular prostheses -Aluminum/Steel- Foot Postural Support Orthosis Dorsal Night Stabilisation Splint GenuMax Knee Joint Support with silicone pads AeroWalker.short, pneumatic transtibial-foot-orthosis PediSupport.dorsal AeroWalker, pneumatic transtibial-foot-orthosis PeroSupport.pro Ankle-Foot-Orthosis, dynamic Peroneal spring, thermoplastic mouldable PeroSupport PeroSupport.tec ComfortSil.soft -6 mm-, without distal connection ContexGel.protect, Protective cover for ContexGel.sleeve ContexGel.basic -3 mm-, without distal connection ClassicSil.soft -6 mm-, without distal connection ComfortSil.basic -3 mm-, with distal connection ClearSil.compression, Post surgical compression liner -Set 1- ContexGel.soft -6 mm-, with distal connection ComfortSil.soft -6 mm-, with distal connection ContexGel.soft+ -9 mm-, with distal connection DuoSil.basic, with distal connection Skin-Care Liner -3 mm- DAW-Slipper, donning aid for AK-prostheses ClassicSil.soft -6 mm-, with distal connection ContexGel.sleeve, Knee Sleeve ContexGel.protect ClearSil.compression, Post surgical compression liner ContexGel.soft+ -9 mm-, with outer matrix, with distal connection ClearSil.basic, without distal connection ContexGel.basic -3 mm-, with outer matrix; without distal connection ContexGel.soft+ -9 mm-, with outer matrix, without distal connection ContexGel.soft -6 mm-, with outer matrix, without distal connection ClassicSil.basic -3 mm-, without distal connection AK-Control.Sil -2 mm-, with distal connection, without silicone strip ContexGel.basic -3 mm-, with distal connection ClassicSil.basic -3 mm-, with distal connection ComfortSil.basic -3 mm-, without distal connection ContexGel.basic -3 mm-, with outer matrix; with distal connection ContexGel.soft+ -9 mm-, without distal connection ClearSil.basic, with distal connection ContexGel.soft -6 mm-, with outer matrix, with distal connection Gel Liner; Silicone Liner; Above Knee & Below Knee Liner; Post surgical compression Liner; Gel Knee Sleeve AK-Control.Sil -2 mm-, with distal connection, with silicone strip ContexGel.soft -6 mm-, without distal connection Nylon Stocking Terrycloth BK-Stump Sock Silicone Insoles, 3/4 length, with duolastic-cover, Silicone Heel Cup, Silicone Heel Wedge, S.A.C.H. Foot for Men up to 150 kg with Adapter Ankle Block -poplar wood- S.A.C.H. Foot for Men for 225 kg with adapter GO.free Carbon Foot S.A.C.H. Foot Adapter -Stainless Steel- S.A.C.H. Foot for Bathing Ankle Block -PUR- light S.A.C.H. Foot Adapter -Stainless Steel- 150 kg GO.smart Carbon Foot Connection Cap for single-axis-foot Single-Axis-Foot Geriatric-Single-Axis-Foot Pirogoff-Foot S.A.C.H. Foot for Men for 175 kg with adapter Dynamic Foot with split toe Dynamic Foot with closed toe S.A.C.H. Foot with Toes for Children Ankle Block -wood- S.A.C.H. Foot Adapter -Titanium- S.A.C.H. Foot with Split Toe GO.free Carbon Module Single-Axis-Foot Adapter S.A.C.H. Foot Adapter -Aluminum- S.A.C.H. Foot GO.smart Carbon Module SACH Foot for Children with Split Toe Geriatric-Foot light GO.adventure Carbon Module GO.relax Carbon Foot Foot Shell for Carbon Foot GO. Connection Cap for Carbon Foot GO. Wedge set for Carbon Foot GO.free Wedge set for Carbon Foot GO.adventure GO.adventure Carbon Foot Spectra Sock(s) for Carbon Foot GO. GO.relax Carbon Module Transtibial Prosthetic Leg Splint, centered joint head AchilloMax, Achilles Tendon Support with silicone pads, including slide-on assistant Venus - Partial Foot Decompression Shoe, short version Jupiter - Forefoot Relief Shoe Merkur A - Partial Foot Decompression Shoe (Post-Surgical Shoe) Uranus - Partial Foot Decompression Shoe (Post-Surgical Shoe) Mars S - Heel Relief Shoe Komet - Especially low Partial Foot Decompression Shoe in outdoor-design Pluto S - Partial Foot Decompression Shoe (Post-Surgical Shoe) Apollo - Partial Foot Decompression Shoe with zero-heel technology Neptun B - Longterm Surgical Shoe with wide outsole and especially high volume Luna - Longterm Surgical Shoe with 3 removable cushioning soles and reinforced outsole Neptun - Longterm Surgical Shoe Merkur - Forefoot Relief Shoe Mars - Heel Relief Shoe Saturn - Forefoot Relief Shoe AK-Suspender - AK-prosthesis support BK-Suspender - holding aid for BK-prostheses Vacuum Valve, Screw Valve, Flat Rubber Valve -Automatic- or -Plastic Pin-, Active.valve TT, waterproof, Active.valve TF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISY Joint, Knee, External Limb Component Physical Medicine Class 1 890.3420 2018-06-22
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2018-10-19
IQO Device, Prosthesis Alignment Physical Medicine Class 1 890.3025 2018-10-23
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2018-10-31
OHI Orthosis, Foot Drop Physical Medicine Class 1 890.3475 2018-06-22
ISS Prosthesis, Thigh Socket, External Component Physical Medicine Class 1 890.3420 2018-09-21
KYS Insoles, Medical General Hospital Class 1 880.6280 1996-09-26
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2018-10-18
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2018-10-19
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2018-06-18
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2019-05-03
ISP Valve, Prosthesis Physical Medicine Class 1 890.3420 1978-03-21

Official Correspondent

Verena Seitz

US Agent Details

Julie Carver Business: College Park Industries Email: jcarver@college-park.com Phone: (800) 7287950

Related Public Records

Same Entity

Streifeneder ortho.production GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010401. Last updated year: 2026. Please use registration number 8010401 when referencing this establishment in official correspondence.
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