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FDA 510(k)

SOFFBAN ORTHOPEDIC PADDING

K-Number: K832992 · 1983-11-14

ApplicantSmith & Nephew, Inc.
Decision Date1983-11-14
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOFFBAN ORTHOPEDIC PADDING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832992. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFFBAN ORTHOPEDIC PADDING?

SOFFBAN ORTHOPEDIC PADDING is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K832992.

When did SOFFBAN ORTHOPEDIC PADDING receive FDA 510(k) clearance?

SOFFBAN ORTHOPEDIC PADDING received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832992.

Who is the listed applicant for SOFFBAN ORTHOPEDIC PADDING?

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

What is the FDA product code for SOFFBAN ORTHOPEDIC PADDING?

The FDA product code for SOFFBAN ORTHOPEDIC PADDING is ITG.

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Other records listing Smith & Nephew, Inc. as applicant

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K261462LANDMARK Total Knee SystemK261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC GlenoidsK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: ITG)

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.

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K862115DEKNA BAND KITDeknatel, Inc.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel MedicalK833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832237ORTHOPEDIC CASTING TAPE MAXCASTCutter Laboratories, Inc.

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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