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FDA 510(k)

ANSPACH MINI-PLATING SYSTEM

K-Number: K921338 · 1993-02-10

ApplicantThe Anspach Effort, Inc.
Decision Date1993-02-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANSPACH MINI-PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 1993-02-10 under 510(k) number K921338. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSPACH MINI-PLATING SYSTEM?

ANSPACH MINI-PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1993-02-10. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K921338.

When did ANSPACH MINI-PLATING SYSTEM receive FDA 510(k) clearance?

ANSPACH MINI-PLATING SYSTEM received FDA 510(k) clearance on 1993-02-10, under 510(k) number K921338.

Who is the listed applicant for ANSPACH MINI-PLATING SYSTEM?

The FDA 510(k) record lists The Anspach Effort, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANSPACH MINI-PLATING SYSTEM?

The FDA product code for ANSPACH MINI-PLATING SYSTEM is HRS.

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Other records listing The Anspach Effort, Inc. 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.

K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)K183545Anspach Helix Dissection ToolsK180063OCM-G1 AttachmentK131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMK113476ANSPACH DISSECTION TOOLSK082637CRANIAL PERFORATOR

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Official Source

View on FDA Database →

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

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