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FDA 510(k)

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM

K-Number: K061362 · 2006-10-06

ApplicantPlus Orthopedics AG
Decision Date2006-10-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics AG. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K061362. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM?

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Plus Orthopedics AG. The 510(k) number is K061362.

When did PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM receive FDA 510(k) clearance?

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM received FDA 510(k) clearance on 2006-10-06, under 510(k) number K061362.

Who is the listed applicant for PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM?

The FDA 510(k) record lists Plus Orthopedics AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM?

The FDA product code for PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM is HAW.

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Other records listing Plus Orthopedics AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070928CERAMIC BALL HEADS, 28, 32 AND 36 MMK070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEMK070278POLARCUP DUAL MOBILITY SYSTEMK063578PROMOS MODULAR SHOULDER SYSTEM

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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