FDA device listing
B.K. Socket Adapter-Titanium,Derma Seal forte,Derma Seal Gel Socks,Double Adapter,Dynamic Vacuum System,Eingussanker…
FDA device listing 1953110895 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | B.K. Socket Adapter-Titanium,Derma Seal forte,Derma Seal Gel Socks,Double Adapter,Dynamic Vacuum System,Eingussanker, gew. Arm, JK,Klima-Arm Liner,Knee Cap, reinforced,lam. Anchor f. water resist. Prothesis,Lamination Anchor,Lamination Anchor with angled arm,Lamination Ring up to 150 kg,MagnoFlex Lock,ProSeal Ring,Rotatable 4 prong Adapter with adj screws,Rotatable 4 prong Adapter with… |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | ISS |
| Device names | ISS - Prosthesis, Thigh Socket, External Component |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3420 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK HEALTHCARE CANADA, OTTO BOCK HEALTHCARE LP, Otto Bock Healthcare Products GmbH, Ottobock Manufacturing Bulgaria EOOD, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 1721652, 9616494, 1000228440, 3005190268, 3018070833 |
| FEI numbers | 1721652, 1000228440, 3003117657, 3005190268, 3018070833 |
| Establishment operations | Contract Manufacturer, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database