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FDA 510(k)

BAUMER LOCKING NAIL

K-Number: K011504 · 2001-08-14

ApplicantBaumer, S.A
Decision Date2001-08-14
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER LOCKING NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Baumer, S.A. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K011504. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAUMER LOCKING NAIL?

BAUMER LOCKING NAIL is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Baumer, S.A. The 510(k) number is K011504.

When did BAUMER LOCKING NAIL receive FDA 510(k) clearance?

BAUMER LOCKING NAIL received FDA 510(k) clearance on 2001-08-14, under 510(k) number K011504.

Who is the listed applicant for BAUMER LOCKING NAIL?

The FDA 510(k) record lists Baumer, S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAUMER LOCKING NAIL?

The FDA product code for BAUMER LOCKING NAIL is JDS.

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Other records listing Baumer, S.A 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.

K003976BAUMER MULLER HIP PROSTHESISK003975BAUMER CEMENTED HIP PROSTHESISK001571BAUMER FEMORAL HEAD

Related Devices (Code: JDS)

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.

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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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